Trial record 1 of 1 for: NCT04513717

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Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial

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ClinicalTrials.gov Identifier: NCT04513717

Recruitment Status : Recruiting

First Posted : August 14, 2020

Last Update Posted : November 25, 2022

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

NRG Oncology

Study Description

Brief Summary:

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Condition or disease	Intervention/treatment	Phase
Metastatic Malignant Neoplasm in the Bone Prostate Adenocarcinoma Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8	Drug: Apalutamide Drug: Bicalutamide Drug: Buserelin Drug: Degarelix Drug: Flutamide Drug: Goserelin Drug: Histrelin Drug: Leuprolide Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Drug: Triptorelin	Phase 3

Show detailed description

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of 24 months ADT+RT and experience non-inferior metastasis-free survival. (De-intensification study) II. To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (> 0.85) or have node-positive disease by conventional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT. (Intensification study)

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) II. To compare time to prostate specific antigen (PSA) failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) III. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) IV. To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) V. To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VI. To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VII. To compare time to testosterone recovery (defined as a T > 200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VIII. To compare adverse events, both clinician-reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and patient-reported using Patient Reported Outcome (PRO)-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

CORRELATIVE STUDIES OBJECTIVE:

I. To compare extra-prostatic uptake on the positron emission tomography (PET)-CT between the standard of care (RT plus 24 months of ADT) and intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification study)

EXPLORATORY OBJECTIVES:

I. To compare changes in cardio-metabolic markers, including body mass index, and waist circumference, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) II. To determine a machine learning/artificial intelligence algorithm for radiotherapy quality assurance. (De-intensification and Intensification studies) III. To perform future translational correlative studies using biological and imaging data. (De-intensification and intensification studies)

PATIENT-REPORTED OUTCOMES OBJECTIVES:

PRIMARY OBJECTIVES:

I. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

SECONDARY OBJECTIVES:

I. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

EXPLORATORY OBJECTIVES:

I. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) III. To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) IV. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study) V. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study) VI. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

OUTLINE: Patients are randomized to 1 of 4 arms.

DE-INTENSIFICATION STUDY (DECIPHER SCORE =< 0.85):

ARM I: Patients undergo radiation therapy (RT) over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.

INTENSIFICATION STUDY (DECIPHER SCORE > 0.85 OR NODE POSITIVE):

ARM III: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide orally (PO) once daily (QD). Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2478 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)
Actual Study Start Date :	December 15, 2020
Estimated Primary Completion Date :	December 31, 2033
Estimated Study Completion Date :	December 31, 2033

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm I (de-intensification study) Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.	Drug: Bicalutamide Antiandrogen Other Names: Casodex Cosudex ICI 176,334 ICI 176334 Drug: Buserelin Luteinizing hormone-releasing hormone (LHRH) agonist Other Names: 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig) BSRL Busereline Etilamide HOE 766 ICI 123215 S74-6766 Drug: Degarelix Gonadotropin-releasing hormone (GnRH) antagonist Other Names: FE200486 Firmagon Drug: Flutamide Antiandrogen Other Names: 4'-Nitro-3'-trifluoromethylisobutyranilide Apimid Cebatrol Chimax Cytomid Drogenil Euflex Eulexine Flucinom Flucinome Flugerel Fluken Flulem FLUT Fluta-Gry Flutabene Flutacan Flutamex Flutamin Flutan Flutaplex Fugerel Grisetin Niftolide Oncosal Profamid Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)- Prostacur Prostadirex Prostica Prostogenat Sch 13521 Tafenil Tecnoflut Testotard Drug: Goserelin Gonadotropin-releasing hormone (GnRH) agonist Other Name: ICI-118630 Drug: Histrelin Gonadotropin-releasing hormone (GnRH) agonist Drug: Leuprolide Gonadotropin-releasing hormone (GnRH) agonist Other Name: Leuprorelin Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Drug: Triptorelin Gonadotropin-releasing hormone (GnRH) agonist Other Names: 6-D-Tryptophan-LH-RH 6-D-Tryptophanluteinizing Hormone-releasing Factor AY-25650 CL-118,532 Detryptoreline
Experimental: Arm II (de-intensification study) Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.	Drug: Bicalutamide Antiandrogen Other Names: Casodex Cosudex ICI 176,334 ICI 176334 Drug: Buserelin Luteinizing hormone-releasing hormone (LHRH) agonist Other Names: 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig) BSRL Busereline Etilamide HOE 766 ICI 123215 S74-6766 Drug: Degarelix Gonadotropin-releasing hormone (GnRH) antagonist Other Names: FE200486 Firmagon Drug: Flutamide Antiandrogen Other Names: 4'-Nitro-3'-trifluoromethylisobutyranilide Apimid Cebatrol Chimax Cytomid Drogenil Euflex Eulexine Flucinom Flucinome Flugerel Fluken Flulem FLUT Fluta-Gry Flutabene Flutacan Flutamex Flutamin Flutan Flutaplex Fugerel Grisetin Niftolide Oncosal Profamid Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)- Prostacur Prostadirex Prostica Prostogenat Sch 13521 Tafenil Tecnoflut Testotard Drug: Goserelin Gonadotropin-releasing hormone (GnRH) agonist Other Name: ICI-118630 Drug: Histrelin Gonadotropin-releasing hormone (GnRH) agonist Drug: Leuprolide Gonadotropin-releasing hormone (GnRH) agonist Other Name: Leuprorelin Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Drug: Triptorelin Gonadotropin-releasing hormone (GnRH) agonist Other Names: 6-D-Tryptophan-LH-RH 6-D-Tryptophanluteinizing Hormone-releasing Factor AY-25650 CL-118,532 Detryptoreline
Active Comparator: Arm III (intensification study) Patients undergo RT over 2-11 weeks and receive ADT as in Arm I.	Drug: Bicalutamide Antiandrogen Other Names: Casodex Cosudex ICI 176,334 ICI 176334 Drug: Buserelin Luteinizing hormone-releasing hormone (LHRH) agonist Other Names: 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig) BSRL Busereline Etilamide HOE 766 ICI 123215 S74-6766 Drug: Degarelix Gonadotropin-releasing hormone (GnRH) antagonist Other Names: FE200486 Firmagon Drug: Flutamide Antiandrogen Other Names: 4'-Nitro-3'-trifluoromethylisobutyranilide Apimid Cebatrol Chimax Cytomid Drogenil Euflex Eulexine Flucinom Flucinome Flugerel Fluken Flulem FLUT Fluta-Gry Flutabene Flutacan Flutamex Flutamin Flutan Flutaplex Fugerel Grisetin Niftolide Oncosal Profamid Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)- Prostacur Prostadirex Prostica Prostogenat Sch 13521 Tafenil Tecnoflut Testotard Drug: Goserelin Gonadotropin-releasing hormone (GnRH) agonist Other Name: ICI-118630 Drug: Histrelin Gonadotropin-releasing hormone (GnRH) agonist Drug: Leuprolide Gonadotropin-releasing hormone (GnRH) agonist Other Name: Leuprorelin Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Drug: Triptorelin Gonadotropin-releasing hormone (GnRH) agonist Other Names: 6-D-Tryptophan-LH-RH 6-D-Tryptophanluteinizing Hormone-releasing Factor AY-25650 CL-118,532 Detryptoreline
Experimental: Arm IV (intensification study) Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide PO QD. Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.	Drug: Apalutamide Nonsteroidal Antiandrogen Other Names: ARN 509 ARN-509 ARN509 Erleada JNJ 56021927 JNJ-56021927 Drug: Buserelin Luteinizing hormone-releasing hormone (LHRH) agonist Other Names: 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig) BSRL Busereline Etilamide HOE 766 ICI 123215 S74-6766 Drug: Degarelix Gonadotropin-releasing hormone (GnRH) antagonist Other Names: FE200486 Firmagon Drug: Goserelin Gonadotropin-releasing hormone (GnRH) agonist Other Name: ICI-118630 Drug: Histrelin Gonadotropin-releasing hormone (GnRH) agonist Drug: Leuprolide Gonadotropin-releasing hormone (GnRH) agonist Other Name: Leuprorelin Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Drug: Triptorelin Gonadotropin-releasing hormone (GnRH) agonist Other Names: 6-D-Tryptophan-LH-RH 6-D-Tryptophanluteinizing Hormone-releasing Factor AY-25650 CL-118,532 Detryptoreline

Outcome Measures

Primary Outcome Measures :

Metastasis-free survival (MFS) [ Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years ]
Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).

Secondary Outcome Measures :

MFS [ Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years ]
Assessed based on standard or molecular, if available, imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958)
Overall survival [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years ]
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).
Prostate cancer specific mortality (PCSM) [ Time Frame: From the date of randomization to the date of prostate cancer death, assessed up to 13 years ]
Prostate specific antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies [ Time Frame: From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years ]
PSA failure-free survival will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).
Time to testosterone recovery [ Time Frame: Up to 13 years ]
Defined as testosterone that is non-castrate.
Time to PSA failure or salvage therapy [ Time Frame: Up to 13 years ]
Testosterone levels at the time of PSA failure and metastases [ Time Frame: Up to 13 years ]
Incidence of adverse events [ Time Frame: Up to 13 years ]
Measured by the Common Terminology Criteria for Adverse Events (CTCAE ) version (v) 5.0 and Patient Reported Outcomes (PRO)-CTCAE.

Other Outcome Measures:

Cardio-metabolic markers including body mass index and waist circumference [ Time Frame: Up to 13 years ]
Machine learning/artificial intelligence algorithm [ Time Frame: Up to 13 years ]
Bowel and urinary quality of life (De-intensification study) [ Time Frame: Up to 13 years ]
Measured by EPIC-26 bowel and urinary domains.
Cognition (De-intensification study) [ Time Frame: Up to 13 years ]
Measured by the Functional Assessment of Chronic Illness Therapy-Cognition (FACIT-Cog) perceived cognitive abilities subscale.
Sexual, hormonal, bowel, and urinary quality of life (Intensification study) [ Time Frame: Up to 13 years ]
Measured by Expanded Prostate Cancer Index Composite-26.
Cognition (Intensification study) [ Time Frame: Up to 13 years ]
Measured by the FACIT-Cog perceived cognitive abilities subscale.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PRIOR TO STEP 1 REGISTRATION
Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
High-risk disease defined as having at least one or more of the following:
- PSA > 20 ng/mL prior to starting ADT
- cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
- Gleason score of 8-10
- Node positive by conventional imaging with a short axis of at least 1.0 cm
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 120 days prior to registration;
- Bone imaging within 120 days prior to registration;
  - Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
- CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
- Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by >= 10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure =< 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
Age >= 18
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
- For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
- Either a CrCl >= 30 ml/min or calculated glomerular filtration rate (GFR) >= 30 will make a patient eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)
- Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 120 days prior to registration)
Serum albumin >= 3.0 g/dL (within 120 days prior to registration)
The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count >= 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
PRIOR TO STEP 2 RANDOMIZATION
Confirmation of Decipher score
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

Exclusion Criteria:

PRIOR TO STEP 1 REGISTRATION:
Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
Prior systemic chemotherapy within =< 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
Prior radical prostatectomy
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
History of any of the following:
- Seizure disorder
- Current severe or unstable angina
- New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
- History of any condition that in the opinion of the investigator, would preclude participation in this study
Evidence of any of the following at registration:
- Active uncontrolled infection requiring IV antibiotics
- Baseline severe hepatic impairment (Child Pugh Class C)
- Inability to swallow oral pills
- Any current condition that in the opinion of the investigator, would preclude participation in this study
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is =< 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
PRIOR TO STEP 2 RANDOMIZATION:
Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513717

Locations

Show 289 study locations

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United States, Alaska
Fairbanks Memorial Hospital	Recruiting
Fairbanks, Alaska, United States, 99701
Contact: Site Public Contact 907-458-3043 Veronica.Stevenson@foundationhealth.org
Principal Investigator: Nicholas DiBella
United States, Arizona
Arizona Breast Cancer Specialists-Gilbert	Recruiting
Gilbert, Arizona, United States, 85297
Contact: Site Public Contact 480-922-4600
Principal Investigator: Christopher A. Biggs
Arizona Center for Cancer Care-Peoria	Recruiting
Peoria, Arizona, United States, 85381
Contact: Site Public Contact 623-773-2873
Principal Investigator: Christopher A. Biggs
Arizona Breast Cancer Specialists-Scottsdale	Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Site Public Contact 480-922-4600
Principal Investigator: Christopher A. Biggs
United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Site Public Contact 501-686-8274
Principal Investigator: Sanjay Maraboyina
United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org
Principal Investigator: Tanya B. Dorff
Washington Hospital	Recruiting
Fremont, California, United States, 94538
Contact: Site Public Contact 510-745-6433
Principal Investigator: Jes Alexander
Marin General Hospital	Recruiting
Greenbrae, California, United States, 94904
Contact: Site Public Contact 415-925-7325
Principal Investigator: Lloyd T. Miyawaki
UC San Diego Moores Cancer Center	Recruiting
La Jolla, California, United States, 92093
Contact: Site Public Contact 858-822-5354 cancercto@ucsd.edu
Principal Investigator: Tyler M. Seibert
City of Hope Antelope Valley	Recruiting
Lancaster, California, United States, 93534
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org
Principal Investigator: Tanya B. Dorff
Los Angeles County-USC Medical Center	Active, not recruiting
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center	Active, not recruiting
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Site Public Contact 310-423-8965
Principal Investigator: Zachary S. Zumsteg
Fremont - Rideout Cancer Center	Recruiting
Marysville, California, United States, 95901
Contact: Site Public Contact 530-749-4400
Principal Investigator: Richard K. Valicenti
UC Irvine Health/Chao Family Comprehensive Cancer Center	Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact 877-827-8839 ucstudy@uci.edu
Principal Investigator: Steven N. Seyedin
Stanford Cancer Institute Palo Alto	Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact 650-498-7061 ccto-office@stanford.edu
Principal Investigator: Hilary Bagshaw
University of California Davis Comprehensive Cancer Center	Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact 916-734-3089
Principal Investigator: Richard K. Valicenti
UCSF Medical Center-Mission Bay	Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact 877-827-3222 cancertrials@ucsf.edu
Principal Investigator: Bradley C. Ekstrand
UCSF Cancer Center - San Mateo	Recruiting
San Mateo, California, United States, 94402
Contact: Site Public Contact 877-827-3222 cancertrials@ucsf.edu
Principal Investigator: Bradley C. Ekstrand
City of Hope South Pasadena	Recruiting
South Pasadena, California, United States, 91030
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org
Principal Investigator: Tanya B. Dorff
Torrance Memorial Physician Network - Cancer Care	Recruiting
Torrance, California, United States, 90505
Contact: Site Public Contact 310-750-3300 courtney.steeneken@tmphysicians.com
Principal Investigator: Zachary S. Zumsteg
Torrance Memorial Medical Center	Recruiting
Torrance, California, United States, 90509
Contact: Site Public Contact 310-517-4665
Principal Investigator: Zachary S. Zumsteg
Gene Upshaw Memorial Tahoe Forest Cancer Center	Recruiting
Truckee, California, United States, 96161
Contact: Site Public Contact 530-582-6450
Principal Investigator: Richard K. Valicenti
United States, Colorado
University of Colorado Hospital	Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact 720-848-0650
Principal Investigator: Tyler Robin
UCHealth Memorial Hospital Central	Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Site Public Contact 719-365-2406
Principal Investigator: Tyler Robin
Memorial Hospital North	Recruiting
Colorado Springs, Colorado, United States, 80920
Contact: Site Public Contact 719-364-6700
Principal Investigator: Tyler Robin
Shaw Cancer Center	Recruiting
Edwards, Colorado, United States, 81632
Contact: Site Public Contact 970-569-7429
Principal Investigator: Patricia H. Hardenbergh
Poudre Valley Hospital	Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Site Public Contact 970-297-6150
Principal Investigator: Tyler Robin
Cancer Care and Hematology-Fort Collins	Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Tyler Robin
UCHealth Greeley Hospital	Recruiting
Greeley, Colorado, United States, 80631
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Tyler Robin
UCHealth Highlands Ranch Hospital	Recruiting
Highlands Ranch, Colorado, United States, 80129
Contact: Site Public Contact 720-848-0650
Principal Investigator: Tyler Robin
Medical Center of the Rockies	Recruiting
Loveland, Colorado, United States, 80538
Contact: Site Public Contact 970-203-7083
Principal Investigator: Tyler Robin
United States, Connecticut
Hartford HealthCare - Saint Vincent's Medical Center	Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Site Public Contact 860-972-4700
Principal Investigator: Christopher M. Iannuzzi
Hartford Hospital	Recruiting
Hartford, Connecticut, United States, 06102
Contact: Site Public Contact 860-545-5363
Principal Investigator: Christopher M. Iannuzzi
United States, Delaware
Bayhealth Hospital Kent Campus	Recruiting
Dover, Delaware, United States, 19901
Contact: Site Public Contact 302-744-6755 mary_ella_quillen@bayhealth.org
Principal Investigator: Iftekhar A. Khan
Helen F Graham Cancer Center	Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact 302-623-4450 mhayden@christianacare.org
Principal Investigator: Gregory A. Masters
Medical Oncology Hematology Consultants PA	Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact 302-623-4450 mhayden@christianacare.org
Principal Investigator: Gregory A. Masters
United States, Florida
University of Florida Health Science Center - Gainesville	Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact 352-273-8010 cancer-center@ufl.edu
Principal Investigator: Jonathan A. Chatzkel
GenesisCare USA - Lakewood Ranch	Recruiting
Lakewood Ranch, Florida, United States, 34202
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
GenesisCare USA - Plantation	Recruiting
Plantation, Florida, United States, 33324
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
United States, Georgia
Grady Health System	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Site Public Contact 404-489-9164
Principal Investigator: Ashesh B. Jani
Emory Proton Therapy Center	Recruiting
Atlanta, Georgia, United States, 30308
Contact: Site Public Contact 404-251-2854 allyson.anderson@emory.edu
Principal Investigator: Ashesh B. Jani
Emory University Hospital Midtown	Recruiting
Atlanta, Georgia, United States, 30308
Contact: Site Public Contact 888-946-7447
Principal Investigator: Ashesh B. Jani
Emory University Hospital/Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact 404-778-1868
Principal Investigator: Ashesh B. Jani
Emory Saint Joseph's Hospital	Recruiting
Atlanta, Georgia, United States, 30342
Contact: Site Public Contact 404-851-7115
Principal Investigator: Ashesh B. Jani
United States, Illinois
Rush - Copley Medical Center	Recruiting
Aurora, Illinois, United States, 60504
Contact: Site Public Contact 630-978-6212 Cancer.Research@rushcopley.com
Principal Investigator: Daniel H. Barnett
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact 312-695-1301 cancer@northwestern.edu
Principal Investigator: Sean Sachdev
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact 312-942-5498 clinical_trials@rush.edu
Principal Investigator: Dian Wang
University of Illinois	Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact 312-355-3046
Principal Investigator: Matthew Koshy
University of Chicago Comprehensive Cancer Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact 773-702-8222 cancerclinicaltrials@bsd.uchicago.edu
Principal Investigator: Stanley L. Liauw
Carle on Vermilion	Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact 800-446-5532 Research@carle.com
Principal Investigator: Daniel H. Barnett
Decatur Memorial Hospital	Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact 217-876-4762 morganthaler.jodi@mhsil.com
Principal Investigator: Bryan A. Faller
Northwestern Medicine Cancer Center Kishwaukee	Recruiting
DeKalb, Illinois, United States, 60115
Contact: Site Public Contact 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Sean Sachdev
Crossroads Cancer Center	Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact 217-876-4762 morganthaler.jodi@mhsil.com
Principal Investigator: Bryan A. Faller
Elmhurst Memorial Hospital	Recruiting
Elmhurst, Illinois, United States, 60126
Contact: Site Public Contact 630-758-5460 Jrohde@emhc.org
Principal Investigator: Brian C. Myre
Northwestern Medicine Cancer Center Delnor	Recruiting
Geneva, Illinois, United States, 60134
Contact: Site Public Contact 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Amit D. Bhate
Northwestern Medicine Lake Forest Hospital	Recruiting
Lake Forest, Illinois, United States, 60045
Contact: Site Public Contact cancertrials@northwestern.edu
Principal Investigator: Sean Sachdev
Carle Physician Group-Mattoon/Charleston	Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact 800-446-5532 Research@carle.com
Principal Investigator: Daniel H. Barnett
Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Public Contact 708-226-4357
Principal Investigator: Abhishek A. Solanki
Edward Hospital/Cancer Center	Recruiting
Naperville, Illinois, United States, 60540
Contact: Site Public Contact 630-646-6075
Principal Investigator: Brian C. Myre
OSF Saint Francis Medical Center	Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact 309-243-3605 andersonj@illinoiscancercare.com
Principal Investigator: Bryan A. Faller
SwedishAmerican Regional Cancer Center/ACT	Recruiting
Rockford, Illinois, United States, 61114
Contact: Site Public Contact 779-696-9400 cancercare@swedishamerican.org
Principal Investigator: Harvey E. Einhorn
Memorial Medical Center	Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact 217-528-7541 pallante.beth@mhsil.com
Principal Investigator: Bryan A. Faller
Carle Cancer Center	Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact 800-446-5532 Research@carle.com
Principal Investigator: Daniel H. Barnett
Northwestern Medicine Cancer Center Warrenville	Recruiting
Warrenville, Illinois, United States, 60555
Contact: Site Public Contact 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Amit D. Bhate
United States, Iowa
Saint Luke's Hospital	Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: Site Public Contact 319-368-5514 Rachel.varner@unitypoint.org
Principal Investigator: Robert J. Isaak
Iowa Methodist Medical Center	Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact 515-241-6727
Principal Investigator: Joshua Lukenbill
Medical Oncology and Hematology Associates-Des Moines	Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact 515-241-3305
Principal Investigator: Joshua Lukenbill
Broadlawns Medical Center	Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact 515-282-2200
Principal Investigator: Joshua Lukenbill
United States, Kansas
University of Kansas Cancer Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Site Public Contact 913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator: Xinglei Shen
University of Kansas Cancer Center-Overland Park	Recruiting
Overland Park, Kansas, United States, 66210
Contact: Site Public Contact 913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator: Xinglei Shen
University of Kansas Health System Saint Francis Campus	Recruiting
Topeka, Kansas, United States, 66606
Contact: Site Public Contact 785-295-8000
Principal Investigator: Xinglei Shen
University of Kansas Hospital-Westwood Cancer Center	Recruiting
Westwood, Kansas, United States, 66205
Contact: Site Public Contact 913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator: Xinglei Shen
Ascension Via Christi Hospitals Wichita	Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact 800-362-0070 Keisha.humphries@ascension.org
Principal Investigator: Shaker R. Dakhil
United States, Louisiana
East Jefferson General Hospital	Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact 504-210-3539 emede1@lsuhsc.edu
Principal Investigator: Scott E. Delacroix
LSU Healthcare Network / Metairie Multi-Specialty Clinic	Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact 504-210-3539 emede1@lsuhsc.edu
Principal Investigator: Scott E. Delacroix
Tulane University Health Sciences Center	Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Site Public Contact 504-988-6121
Principal Investigator: Kendra M. Harris
United States, Maine
MaineHealth Coastal Cancer Treatment Center	Recruiting
Bath, Maine, United States, 04530
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Matthew D. Cheney
Maine Medical Center-Bramhall Campus	Recruiting
Portland, Maine, United States, 04102
Contact: Site Public Contact 207-885-7565
Principal Investigator: Matthew D. Cheney
Penobscot Bay Medical Center	Recruiting
Rockport, Maine, United States, 04856
Contact: Site Public Contact 207-396-8670 ClinicalResearch@mmc.org
Principal Investigator: Matthew D. Cheney
MaineHealth Cancer Care Center of York County	Recruiting
Sanford, Maine, United States, 04073
Contact: Site Public Contact 207-459-1600
Principal Investigator: Matthew D. Cheney
Maine Medical Center- Scarborough Campus	Recruiting
Scarborough, Maine, United States, 04074
Contact: Site Public Contact 207-396-8090 wrighd@mmc.org
Principal Investigator: Matthew D. Cheney
Maine Medical Partners - South Portland	Recruiting
South Portland, Maine, United States, 04106
Contact: Site Public Contact 207-396-8670 ClinicalResearch@mmc.org
Principal Investigator: Matthew D. Cheney
United States, Massachusetts
Massachusetts General Hospital Cancer Center	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact 877-726-5130
Principal Investigator: Jason A. Efstathiou
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Site Public Contact 617-724-5200
Principal Investigator: Paul L. Nguyen
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact 877-442-3324
Principal Investigator: Paul L. Nguyen
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional	Recruiting
Milford, Massachusetts, United States, 01757
Contact: Site Public Contact 877-332-4294
Principal Investigator: Peter F. Orio
Dana-Farber/Brigham and Women's Cancer Center at South Shore	Recruiting
South Weymouth, Massachusetts, United States, 02190
Contact: Site Public Contact 781-624-5000
Principal Investigator: Peter F. Orio
United States, Michigan
Saint Joseph Mercy Hospital	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact 800-865-1125
Principal Investigator: Robert Dess
Trinity Health IHA Medical Group Hematology Oncology - Brighton	Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
University of Michigan - Brighton Center for Specialty Care	Recruiting
Brighton, Michigan, United States, 48116
Contact: Site Public Contact 800-865-1125
Principal Investigator: Robert Dess
Henry Ford Cancer Institute-Downriver	Suspended
Brownstown, Michigan, United States, 48183
Saint Joseph Mercy Canton	Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
Trinity Health IHA Medical Group Hematology Oncology - Canton	Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
Saint Joseph Mercy Chelsea	Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital	Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
GenesisCare USA - Clarkston	Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
Henry Ford Macomb Hospital-Clinton Township	Recruiting
Clinton Township, Michigan, United States, 48038
Contact: Site Public Contact 313-916-3721 CTOResearch@hfhs.org
Principal Investigator: Eleanor M. Walker
Beaumont Hospital - Dearborn	Recruiting
Dearborn, Michigan, United States, 48124
Contact: Site Public Contact 248-551-7695
Principal Investigator: Daniel J. Krauss
Henry Ford Medical Center-Fairlane	Suspended
Dearborn, Michigan, United States, 48126
Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Contact: Site Public Contact 313-916-3721 CTOResearch@hfhs.org
Principal Investigator: Eleanor M. Walker
GenesisCare USA - Farmington Hills	Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
Mercy Health Saint Mary's	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
Bronson Methodist Hospital	Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
West Michigan Cancer Center	Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
Trinity Health Saint Mary Mercy Livonia Hospital	Recruiting
Livonia, Michigan, United States, 48154
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
GenesisCare USA - Macomb	Recruiting
Macomb, Michigan, United States, 48044
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
GenesisCare USA - Madison Heights	Recruiting
Madison Heights, Michigan, United States, 48071
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
Henry Ford Medical Center-Columbus	Suspended
Novi, Michigan, United States, 48377
William Beaumont Hospital-Royal Oak	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact 248-551-7695
Principal Investigator: Daniel J. Krauss
Ascension Saint Mary's Hospital	Recruiting
Saginaw, Michigan, United States, 48601
Contact: Site Public Contact 989-907-8411 lori.srebinski@ascension.org
Principal Investigator: Samir Narayan
Henry Ford Macomb Health Center - Shelby Township	Suspended
Shelby, Michigan, United States, 48315
Munson Medical Center	Recruiting
Traverse City, Michigan, United States, 49684
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
William Beaumont Hospital - Troy	Recruiting
Troy, Michigan, United States, 48085
Contact: Site Public Contact 248-551-7695
Principal Investigator: Daniel J. Krauss
GenesisCare USA - Troy	Recruiting
Troy, Michigan, United States, 48098
Contact: Site Public Contact 941-833-5700 Rudi.Ross@usa.genesiscare.com
Principal Investigator: Frank A. Vicini
Henry Ford West Bloomfield Hospital	Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Site Public Contact 313-916-3721 CTOResearch@hfhs.org
Principal Investigator: Eleanor M. Walker
Metro Health Hospital	Recruiting
Wyoming, Michigan, United States, 49519
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus	Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Site Public Contact 734-712-7251 MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Samir Narayan
United States, Minnesota
Mayo Clinic Health System in Albert Lea	Recruiting
Albert Lea, Minnesota, United States, 56007
Contact: Site Public Contact 855-776-0015
Principal Investigator: Bradley J. Stish
Miller-Dwan Hospital	Recruiting
Duluth, Minnesota, United States, 55805
Contact: Site Public Contact 218-786-3308 CancerTrials@EssentiaHealth.org
Principal Investigator: Bret E. Friday
Unity Hospital	Recruiting
Fridley, Minnesota, United States, 55432
Contact: Site Public Contact 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Charles Shideman
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact 855-776-0015
Principal Investigator: Bradley J. Stish
Regions Hospital	Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Site Public Contact 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Charles Shideman
United States, Missouri
Saint Francis Medical Center	Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact 573-334-2230 sfmc@sfmc.net
Principal Investigator: Bryan A. Faller
University of Missouri - Ellis Fischel	Recruiting
Columbia, Missouri, United States, 65212
Contact: Site Public Contact 573-882-7440
Principal Investigator: Gregory B. Biedermann
Siteman Cancer Center at West County Hospital	Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Jeff M. Michalski
Freeman Health System	Recruiting
Joplin, Missouri, United States, 64804
Contact: Site Public Contact 417-347-4030 LJCrockett@freemanhealth.com
Principal Investigator: Jay W. Carlson
University of Kansas Cancer Center - North	Recruiting
Kansas City, Missouri, United States, 64154
Contact: Site Public Contact 913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator: Xinglei Shen
University of Kansas Cancer Center - Lee's Summit	Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Site Public Contact 913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator: Xinglei Shen
University of Kansas Cancer Center at North Kansas City Hospital	Recruiting
North Kansas City, Missouri, United States, 64116
Contact: Site Public Contact 913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator: Xinglei Shen
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Jeff M. Michalski
Siteman Cancer Center-South County	Recruiting
Saint Louis, Missouri, United States, 63129
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Jeff M. Michalski
Siteman Cancer Center at Christian Hospital	Recruiting
Saint Louis, Missouri, United States, 63136
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Jeff M. Michalski
Siteman Cancer Center at Saint Peters Hospital	Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Jeff M. Michalski
Mercy Hospital Springfield	Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact 417-269-4520
Principal Investigator: Jay W. Carlson
United States, Montana
Billings Clinic Cancer Center	Recruiting
Billings, Montana, United States, 59101
Contact: Site Public Contact 800-996-2663 research@billingsclinic.org
Principal Investigator: John M. Schallenkamp
Benefis Healthcare- Sletten Cancer Institute	Recruiting
Great Falls, Montana, United States, 59405
Contact: Site Public Contact 406-969-6060 mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp
United States, New Hampshire
New Hampshire Oncology Hematology PA-Concord	Recruiting
Concord, New Hampshire, United States, 03301
Contact: Site Public Contact 603-224-2556
Principal Investigator: Douglas J. Weckstein
Dartmouth Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact 800-639-6918 cancer.research.nurse@dartmouth.edu
Principal Investigator: Alan C. Hartford
Solinsky Center for Cancer Care	Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Site Public Contact 800-339-6484
Principal Investigator: Douglas J. Weckstein
United States, New Jersey
Cooper Hospital University Medical Center	Recruiting
Camden, New Jersey, United States, 08103
Contact: Site Public Contact 856-325-6757
Principal Investigator: Gary Eastwick
AtlantiCare Surgery Center	Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Site Public Contact 609-748-7200
Principal Investigator: James C. Wurzer
The Cancer Institute of New Jersey Hamilton	Recruiting
Hamilton, New Jersey, United States, 08690
Contact: Site Public Contact 609-631-6946
Principal Investigator: Malcolm D. Mattes
Rutgers Cancer Institute of New Jersey	Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact 732-235-7356
Principal Investigator: Malcolm D. Mattes
The Valley Hospital-Luckow Pavilion	Recruiting
Paramus, New Jersey, United States, 07652
Contact: Site Public Contact 201-634-5792
Principal Investigator: Thomas P. Kole
Valley Hospital	Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Site Public Contact 201-634-5792 cparish@valleyhealth.com
Principal Investigator: Thomas P. Kole
Community Medical Center	Recruiting
Toms River, New Jersey, United States, 08755
Contact: Site Public Contact 732-557-8294 Lennette.Gonzales@rwjbh.org
Principal Investigator: Malcolm D. Mattes
MD Anderson Cancer Center at Cooper-Voorhees	Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Site Public Contact 856-325-6757
Principal Investigator: Gary Eastwick
United States, New Mexico
University of New Mexico Cancer Center	Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Site Public Contact 505-925-0366 LByatt@nmcca.org
Principal Investigator: Neda Hashemi Sadraei
Presbyterian Kaseman Hospital	Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Site Public Contact 505-559-6113 WBurman@phs.org
Principal Investigator: Neda Hashemi Sadraei
Presbyterian Rust Medical Center/Jorgensen Cancer Center	Recruiting
Rio Rancho, New Mexico, United States, 87124
Contact: Site Public Contact 505-559-6113 WBurman@phs.org
Principal Investigator: Neda Hashemi Sadraei
United States, New York
New York-Presbyterian/Brooklyn Methodist Hospital	Recruiting
Brooklyn, New York, United States, 11215
Contact: Site Public Contact 718-780-3677 Adg9003@nyp.org
Principal Investigator: Hani L. Ashamalla
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact 800-767-9355 askroswell@roswellpark.org
Principal Investigator: Michael R. Kuettel
Sands Cancer Center	Suspended
Canandaigua, New York, United States, 14424
Noyes Memorial Hospital/Myers Cancer Center	Recruiting
Dansville, New York, United States, 14437
Contact: Site Public Contact WCICTOresearch@urmc.rochester.edu
Principal Investigator: Yuhchyau Chen
The New York Hospital Medical Center of Queens	Recruiting
Flushing, New York, United States, 11355
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Steven J. DiBiase
Glens Falls Hospital	Recruiting
Glens Falls, New York, United States, 12801
Contact: Site Public Contact 518-926-6700
Principal Investigator: Nataniel H. Lester-Coll
Northwell Health/Center for Advanced Medicine	Recruiting
Lake Success, New York, United States, 11042
Contact: Site Public Contact 516-734-8896
Principal Investigator: Louis Potters
NYP/Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact 212-746-1848
Principal Investigator: Himanshu Nagar
Highland Hospital	Recruiting
Rochester, New York, United States, 14620
Contact: Site Public Contact 585-341-8113
Principal Investigator: Yuhchyau Chen
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact 585-275-5830
Principal Investigator: Yuhchyau Chen
Phelps Memorial Hospital Center	Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Site Public Contact 914-366-1600
Principal Investigator: Louis Potters
Stony Brook University Medical Center	Recruiting
Stony Brook, New York, United States, 11794
Contact: Site Public Contact 800-862-2215
Principal Investigator: Alexander N. Slade
State University of New York Upstate Medical University	Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact 315-464-5476
Principal Investigator: Alexander V. Banashkevich
United States, North Carolina
Duke Cancer Institute Cary	Recruiting
Cary, North Carolina, United States, 27518
Contact: Site Public Contact 919-781-7070
Principal Investigator: William R. Lee
Carolinas Medical Center/Levine Cancer Institute	Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact 800-804-9376
Principal Investigator: Matthew C. Ward
Novant Health Presbyterian Medical Center	Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Site Public Contact 980-201-6360 kashah@novanthealth.org
Principal Investigator: Catherine E. Moore
Atrium Health Pineville/LCI-Pineville	Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Site Public Contact 980-442-2000
Principal Investigator: Matthew C. Ward
Atrium Health University City/LCI-University	Recruiting
Charlotte, North Carolina, United States, 28262
Contact: Site Public Contact 800-804-9376
Principal Investigator: Matthew C. Ward
Levine Cancer Institute-Ballantyne	Recruiting
Charlotte, North Carolina, United States, 28277
Contact: Site Public Contact 800-804-9376
Principal Investigator: Matthew C. Ward
Durham VA Medical Center	Recruiting
Durham, North Carolina, United States, 27705
Contact: Site Public Contact 919-286-0411 VHADURcancertrials@va.gov
Principal Investigator: Matthew J. Boyer
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact 888-275-3853
Principal Investigator: William R. Lee
Novant Health Cancer Institute - Huntersville	Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Site Public Contact 980-201-6360 kashah@novanthealth.org
Principal Investigator: Catherine E. Moore
Novant Health Cancer Institute - Matthews	Recruiting
Matthews, North Carolina, United States, 28105
Contact: Site Public Contact 980-201-6360 kashah@novanthealth.org
Principal Investigator: Catherine E. Moore
Novant Health Cancer Institute - Mooresville	Recruiting
Mooresville, North Carolina, United States, 28117
Contact: Site Public Contact 980-201-6360 kashah@novanthealth.org
Principal Investigator: Catherine E. Moore
Duke Raleigh Hospital	Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Site Public Contact 919-862-5400
Principal Investigator: William R. Lee
Novant Cancer Institute Radiation Oncology - Supply	Recruiting
Supply, North Carolina, United States, 28462
Contact: Site Public Contact 910-754-4716
Principal Investigator: Michael A. Papagikos
Novant Health Cancer Institute Radiation Oncology - Wilmington	Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Site Public Contact 910-251-1839
Principal Investigator: Michael A. Papagikos
Novant Health New Hanover Regional Medical Center	Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Site Public Contact 910-342-3000
Principal Investigator: Michael A. Papagikos
United States, Ohio
Summa Health System - Akron Campus	Recruiting
Akron, Ohio, United States, 44304
Contact: Site Public Contact 330-375-4221 cancerresearch@summahealth.org
Principal Investigator: Desiree E. Doncals
Summa Health System - Barberton Campus	Recruiting
Barberton, Ohio, United States, 44203
Contact: Site Public Contact 330-375-4221 cancerresearch@summahealth.org
Principal Investigator: Desiree E. Doncals
Ohio State University Comprehensive Cancer Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Site Public Contact 800-293-5066 Jamesline@osumc.edu
Principal Investigator: Dayssy A. Diaz Pardo
Summa Health Medina Medical Center	Recruiting
Medina, Ohio, United States, 44256
Contact: Site Public Contact 330-375-4221 cancerresearch@summahealth.org
Principal Investigator: Desiree E. Doncals
ProMedica Flower Hospital	Recruiting
Sylvania, Ohio, United States, 43560
Contact: Site Public Contact 419-824-1842 PCIOncResearch@promedica.org
Principal Investigator: Eric P. Kielhorn
United States, Oklahoma
University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact 405-271-8777 ou-clinical-trials@ouhsc.edu
Principal Investigator: Tyler Gunter
United States, Oregon
Legacy Mount Hood Medical Center	Recruiting
Gresham, Oregon, United States, 97030
Contact: Site Public Contact 503-413-2150
Principal Investigator: Andrew Y. Kee
Legacy Good Samaritan Hospital and Medical Center	Recruiting
Portland, Oregon, United States, 97210
Contact: Site Public Contact 800-220-4937 cancer@lhs.org
Principal Investigator: Andrew Y. Kee
Legacy Meridian Park Hospital	Recruiting
Tualatin, Oregon, United States, 97062
Contact: Site Public Contact 503-413-1742
Principal Investigator: Andrew Y. Kee
United States, Pennsylvania
UPMC Altoona	Recruiting
Altoona, Pennsylvania, United States, 16601
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Adam Olson
UPMC-Heritage Valley Health System Beaver	Recruiting
Beaver, Pennsylvania, United States, 15009
Contact: Site Public Contact 412-389-5208 haneydl@upmc.edu
Principal Investigator: Adam Olson
Carlisle Regional Cancer Center	Recruiting
Carlisle, Pennsylvania, United States, 17015
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Adam Olson
Christiana Care Health System-Concord Health Center	Recruiting
Chadds Ford, Pennsylvania, United States, 19317
Contact: Site Public Contact 302-623-4450 mhayden@christianacare.org
Principal Investigator: Gregory A. Masters
Geisinger Medical Center	Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Site Public Contact 570-271-5251 HemonCCTrials@geisinger.edu
Principal Investigator: Heath B. Mackley
Ephrata Cancer Center	Recruiting
Ephrata, Pennsylvania, United States, 17522
Contact: Site Public Contact 717-721-4840
Principal Investigator: Amit B. Shah
UPMC Hillman Cancer Center Erie	Recruiting
Erie, Pennsylvania, United States, 16505
Contact: Site Public Contact 412-389-5208 haneydl@upmc.edu
Principal Investigator: Adam Olson
Saint Vincent Hospital	Recruiting
Erie, Pennsylvania, United States, 16544
Contact: Site Public Contact 814-452-5000
Principal Investigator: Russell Fuhrer
UPMC Cancer Center at UPMC Horizon	Recruiting
Farrell, Pennsylvania, United States, 16121
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Adam Olson
Adams Cancer Center	Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Site Public Contact 877-441-7957
Principal Investigator: Amit B. Shah
UPMC Cancer Centers - Arnold Palmer Pavilion	Recruiting
Greensburg, Pennsylvania, United States, 15601
Contact: Site Public Contact 724-838-1900
Principal Investigator: Adam Olson
UPMC Pinnacle Cancer Center/Community Osteopathic Campus	Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: Site Public Contact 717-724-6765 klitchfield@PINNACLEHEALTH.org
Principal Investigator: Adam Olson
Penn State Milton S Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Site Public Contact 717-531-3779 CTO@hmc.psu.edu
Principal Investigator: Joseph A. Miccio
Jefferson Hospital	Recruiting
Jefferson Hills, Pennsylvania, United States, 15025
Contact: Site Public Contact 412-359-3043 ddefazio@wpahs.org
Principal Investigator: Russell Fuhrer
UPMC-Johnstown/John P. Murtha Regional Cancer Center	Recruiting
Johnstown, Pennsylvania, United States, 15901
Contact: Site Public Contact 814-534-4724
Principal Investigator: Adam Olson
Sechler Family Cancer Center	Recruiting
Lebanon, Pennsylvania, United States, 17042
Contact: Site Public Contact 717-741-8303 doxenberg@wellspan.org
Principal Investigator: Amit B. Shah
Geisinger Medical Oncology-Lewisburg	Recruiting
Lewisburg, Pennsylvania, United States, 17837
Contact: Site Public Contact 570-374-8555 HemonCCTrials@geisinger.edu
Principal Investigator: Heath B. Mackley
UPMC Cancer Center at UPMC McKeesport	Recruiting
McKeesport, Pennsylvania, United States, 15132
Contact: Site Public Contact 412-647-8073
Principal Investigator: Adam Olson
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion	Recruiting
Mechanicsburg, Pennsylvania, United States, 17050
Contact: Site Public Contact 412-389-5208 haneydl@upmc.edu
Principal Investigator: Adam Olson
Forbes Hospital	Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Site Public Contact 412-858-7746
Principal Investigator: Russell Fuhrer
UPMC Cancer Center - Monroeville	Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Site Public Contact 412-339-5294 Roster@nrgoncology.org
Principal Investigator: Adam Olson
UPMC-Coraopolis/Heritage Valley Radiation Oncology	Recruiting
Moon, Pennsylvania, United States, 15108
Contact: Site Public Contact 412-604-2020
Principal Investigator: Adam Olson
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Site Public Contact 215-600-9151 ONCTrialNow@jefferson.edu
Principal Investigator: Adam C. Mueller
Allegheny General Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Site Public Contact 877-284-2000
Principal Investigator: Russell Fuhrer
UPMC-Magee Womens Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Site Public Contact 412-647-2811
Principal Investigator: Adam Olson
UPMC-Saint Margaret	Recruiting
Pittsburgh, Pennsylvania, United States, 15215
Contact: Site Public Contact 412-784-4900
Principal Investigator: Adam Olson
West Penn Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact 412-578-5000
Principal Investigator: Russell Fuhrer
UPMC-Shadyside Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site Public Contact 412-621-2334
Principal Investigator: Adam Olson
UPMC-Passavant Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Site Public Contact 412-367-6454
Principal Investigator: Adam Olson
UPMC-Saint Clair Hospital Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Site Public Contact 412-502-3920
Principal Investigator: Adam Olson
Geisinger Cancer Services-Pottsville	Recruiting
Pottsville, Pennsylvania, United States, 17901
Contact: Site Public Contact 800-275-6401 HemonCCTrials@geisinger.edu
Principal Investigator: Heath B. Mackley
UPMC Cancer Center at UPMC Northwest	Recruiting
Seneca, Pennsylvania, United States, 16346
Contact: Site Public Contact 814-676-7900
Principal Investigator: Adam Olson
UPMC Uniontown Hospital Radiation Oncology	Recruiting
Uniontown, Pennsylvania, United States, 15401
Contact: Site Public Contact 724-437-2503
Principal Investigator: Adam Olson
UPMC Washington Hospital Radiation Oncology	Recruiting
Washington, Pennsylvania, United States, 15301
Contact: Site Public Contact 724-223-3788 cancer@washingtonhospital.org
Principal Investigator: Adam Olson
Reading Hospital	Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Site Public Contact 610-988-9323
Principal Investigator: Michael L. Haas
Wexford Health and Wellness Pavilion	Recruiting
Wexford, Pennsylvania, United States, 15090
Contact: Site Public Contact Dawnmarie.DeFazio@ahn.org
Principal Investigator: Russell Fuhrer
Geisinger Wyoming Valley/Henry Cancer Center	Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Site Public Contact 570-271-5251 HemonCCTrials@geisinger.edu
Principal Investigator: Heath B. Mackley
Asplundh Cancer Pavilion	Suspended
Willow Grove, Pennsylvania, United States, 19090
WellSpan Health-York Cancer Center	Recruiting
York, Pennsylvania, United States, 17403
Contact: Site Public Contact 877-441-7957
Principal Investigator: Amit B. Shah
UPMC Memorial	Recruiting
York, Pennsylvania, United States, 17408
Contact: Site Public Contact 717-724-6760
Principal Investigator: Adam Olson
United States, Rhode Island
Rhode Island Hospital	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact 401-444-1488
Principal Investigator: Paul P. Koffer
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Public Contact 843-792-9321 hcc-clinical-trials@musc.edu
Principal Investigator: David T. Marshall
Saint Francis Cancer Center	Recruiting
Greenville, South Carolina, United States, 29607
Contact: Site Public Contact 864-603-6213 melissa_beckman@bshsi.org
Principal Investigator: Jennifer Vogel
Self Regional Healthcare	Recruiting
Greenwood, South Carolina, United States, 29646
Contact: Site Public Contact 864-725-4771 nmcgaha@selfregional.org
Principal Investigator: David T. Marshall
Gibbs Cancer Center-Pelham	Recruiting
Greer, South Carolina, United States, 29651
Contact: Site Public Contact 864-560-6104 kmertz-rivera@gibbscc.org
Principal Investigator: Drew C. Monitto
Carolina Regional Cancer Center	Recruiting
Myrtle Beach, South Carolina, United States, 29577
Contact: Site Public Contact 877-460-2657
Principal Investigator: Frank A. Vicini
Spartanburg Medical Center	Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Site Public Contact 864-560-6104 kmertz-rivera@gibbscc.org
Principal Investigator: Drew C. Monitto
United States, Tennessee
Thompson Cancer Survival Center	Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact 865-331-1812
Principal Investigator: David D. Chism
United States, Texas
MD Anderson in The Woodlands	Recruiting
Conroe, Texas, United States, 77384
Contact: Site Public Contact 866-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Karen E. Hoffman
Houston Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact 713-790-2700
Principal Investigator: Waqar Haque
M D Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Karen E. Hoffman
MD Anderson West Houston	Recruiting
Houston, Texas, United States, 77079
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Karen E. Hoffman
Houston Methodist West Hospital	Recruiting
Houston, Texas, United States, 77094
Contact: Site Public Contact 832-522-2873
Principal Investigator: Waqar Haque
MD Anderson in Sugar Land	Recruiting
Sugar Land, Texas, United States, 77478
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Karen E. Hoffman
United States, Utah
American Fork Hospital / Huntsman Intermountain Cancer Center	Recruiting
American Fork, Utah, United States, 84003
Contact: Site Public Contact 801-855-4100 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
Farmington Health Center	Recruiting
Farmington, Utah, United States, 84025
Contact: Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu
Principal Investigator: Skyler B. Johnson
Logan Regional Hospital	Recruiting
Logan, Utah, United States, 84321
Contact: Site Public Contact 435-716-6400 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
Intermountain Medical Center	Recruiting
Murray, Utah, United States, 84107
Contact: Site Public Contact 801-507-3950 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
McKay-Dee Hospital Center	Recruiting
Ogden, Utah, United States, 84403
Contact: Site Public Contact 801-387-7426 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
Utah Valley Regional Medical Center	Recruiting
Provo, Utah, United States, 84604
Contact: Site Public Contact 801-357-7965 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
Riverton Hospital	Recruiting
Riverton, Utah, United States, 84065
Contact: Site Public Contact 801-507-3950 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
Saint George Regional Medical Center	Recruiting
Saint George, Utah, United States, 84770
Contact: Site Public Contact 833-321-3332 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
University of Utah Sugarhouse Health Center	Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu
Principal Investigator: Skyler B. Johnson
Utah Cancer Specialists-Salt Lake City	Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Site Public Contact 801-933-6070 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
Huntsman Cancer Institute/University of Utah	Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu
Principal Investigator: Skyler B. Johnson
LDS Hospital	Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Site Public Contact 801-408-1347 officeofresearch@imail.org
Principal Investigator: Brandon M. Barney
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment	Recruiting
Berlin, Vermont, United States, 05602
Contact: Site Public Contact 802-225-5400
Principal Investigator: Nataniel H. Lester-Coll
University of Vermont Medical Center	Recruiting
Burlington, Vermont, United States, 05401
Contact: Site Public Contact 802-656-4101 rpo@uvm.edu
Principal Investigator: Nataniel H. Lester-Coll
Norris Cotton Cancer Center-North	Recruiting
Saint Johnsbury, Vermont, United States, 05819
Contact: Site Public Contact 802-473-4100
Principal Investigator: Alan C. Hartford
United States, Virginia
Inova Schar Cancer Institute	Recruiting
Fairfax, Virginia, United States, 22031
Contact: Site Public Contact 703-720-5210 Stephanie.VanBebber@inova.org
Principal Investigator: Eun-mi Yu
Bon Secours Saint Francis Medical Center	Recruiting
Midlothian, Virginia, United States, 23114
Contact: Site Public Contact 804-893-8663 Jaime_scott@bshsi.org
Principal Investigator: William J. Irvin
Bon Secours Cancer Institute at Reynolds Crossing	Recruiting
Richmond, Virginia, United States, 23230
Contact: Site Public Contact 804-893-8663 Jaime_scott@bshsi.org
Principal Investigator: William J. Irvin
Virginia Commonwealth University/Massey Cancer Center	Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact CTOclinops@vcu.edu
Principal Investigator: Alfredo I. Urdaneta
United States, Washington
Virginia Mason Medical Center	Recruiting
Seattle, Washington, United States, 98101
Contact: Site Public Contact 206-342-6954 vmmc.cancer_clinical_research@VirginiaMason.org
Principal Investigator: Huong T. Pham
Legacy Cancer Institute Medical Oncology and Day Treatment	Recruiting
Vancouver, Washington, United States, 98684
Contact: Site Public Contact oncologyresearch@lhs.org
Principal Investigator: Andrew Y. Kee
Legacy Salmon Creek Hospital	Recruiting
Vancouver, Washington, United States, 98686
Contact: Site Public Contact 503-413-2150
Principal Investigator: Andrew Y. Kee
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center	Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Site Public Contact 304-243-6442
Principal Investigator: Jondavid Pollock
United States, Wisconsin
Langlade Hospital and Cancer Center	Recruiting
Antigo, Wisconsin, United States, 54409
Contact: Site Public Contact 715-623-9869 Juli.Alford@aspirus.org
Principal Investigator: Andrew J. Huang
Northwest Wisconsin Cancer Center	Recruiting
Ashland, Wisconsin, United States, 54806
Contact: Site Public Contact 218-786-3308 CancerTrials@EssentiaHealth.org
Principal Investigator: Bret E. Friday
Aurora Cancer Care-Southern Lakes VLCC	Recruiting
Burlington, Wisconsin, United States, 53105
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Health Care Germantown Health Center	Recruiting
Germantown, Wisconsin, United States, 53022
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Cancer Care-Grafton	Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora BayCare Medical Center	Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Cancer Care-Kenosha South	Recruiting
Kenosha, Wisconsin, United States, 53142
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Mayo Clinic Health System-Franciscan Healthcare	Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Site Public Contact 855-776-0015
Principal Investigator: Bradley J. Stish
Aurora Bay Area Medical Group-Marinette	Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Cancer Care-Milwaukee	Recruiting
Milwaukee, Wisconsin, United States, 53209
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Saint Luke's Medical Center	Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Sinai Medical Center	Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Zablocki Veterans Administration Medical Center	Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Site Public Contact 888-469-6614
Principal Investigator: Elizabeth M. Gore
Vince Lombardi Cancer Clinic - Oshkosh	Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Cancer Care-Racine	Recruiting
Racine, Wisconsin, United States, 53406
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Vince Lombardi Cancer Clinic-Sheboygan	Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora Medical Center in Summit	Recruiting
Summit, Wisconsin, United States, 53066
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Vince Lombardi Cancer Clinic-Two Rivers	Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aspirus Regional Cancer Center	Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Site Public Contact 877-405-6866
Principal Investigator: Andrew J. Huang
Aurora Cancer Care-Milwaukee West	Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aurora West Allis Medical Center	Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Site Public Contact 414-302-2304 ncorp@aurora.org
Principal Investigator: Jeffrey A. Kittel
Aspirus Cancer Care - Wisconsin Rapids	Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Site Public Contact 715-422-7718
Principal Investigator: Andrew J. Huang
Canada, Ontario
University Health Network-Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site Public Contact 416-946-4501 clinical.trials@uhn.on.ca
Principal Investigator: Srinivas Raman

Sponsors and Collaborators

NRG Oncology

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	Paul L Nguyen	NRG Oncology

More Information

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Responsible Party:	NRG Oncology
ClinicalTrials.gov Identifier:	NCT04513717
Other Study ID Numbers:	NRG-GU009 NCI-2020-04705 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NRG-GU009 ( Other Identifier: NRG Oncology ) NRG-GU009 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract )
First Posted:	August 14, 2020 Key Record Dates
Last Update Posted:	November 25, 2022
Last Verified:	November 2022

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Prostatic Neoplasms Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Prostatic Diseases Leuprolide Goserelin Triptorelin Pamoate Flutamide Bicalutamide Tryptophan Buserelin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists	Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Contraceptive Agents, Hormonal Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs

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