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Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03070886
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Brief Summary:
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Condition or disease Intervention/treatment Phase
Stage I Prostate Adenocarcinoma Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma Drug: Bicalutamide Drug: Docetaxel Radiation: External Beam Radiation Therapy Drug: Flutamide Drug: Goserelin Acetate Other: Laboratory Biomarker Analysis Drug: Leuprolide Acetate Drug: Nilutamide Phase 2 Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.

SECONDARY OBJECTIVES:

I. To assess overall survival. II. To assess local time to progression. III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment.

IV. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy.

V. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy.

VI. To assess treatment response by genomically defined sub-groups of prostate cancer patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive external beam radiation therapy (EBRT) for 7.5 weeks.

ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2031

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Active Comparator: Arm I (androgen deprivation therapy, EBRT)
Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
Drug: Bicalutamide
Given orally
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Drug: Flutamide
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 Acetate
Other Names:
  • ZDX
  • Zoladex

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Leuprolide Acetate
Other Names:
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone
  • Enantone-Gyn
  • Ginecrin
  • LEUP
  • Leuplin
  • Leuprorelin Acetate
  • Lucrin
  • Lucrin Depot
  • Lupron
  • Lupron Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur

Drug: Nilutamide
Other Names:
  • Anandron
  • Nilandron
  • RU-23908

Experimental: Arm II (androgen deprivation therapy, EBRT, docetaxel)
Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.
Drug: Bicalutamide
Given orally
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Drug: Flutamide
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 Acetate
Other Names:
  • ZDX
  • Zoladex

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Leuprolide Acetate
Other Names:
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone
  • Enantone-Gyn
  • Ginecrin
  • LEUP
  • Leuplin
  • Leuprorelin Acetate
  • Lucrin
  • Lucrin Depot
  • Lupron
  • Lupron Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur

Drug: Nilutamide
Other Names:
  • Anandron
  • Nilandron
  • RU-23908




Primary Outcome Measures :
  1. Freedom from progression (FFP) (Phase II) [ Time Frame: From time of randomization to first event, assessed up to 43 months ]
    Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by PSA >= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and death from any cause.

  2. Metastasis free survival (MFS) (Phase III) [ Time Frame: From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years ]
    Will be measured with a one-sided stratified log-rank test when 282 MFS events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Time to death from any cause assessed up to 9.5 years ]
    Will be analyzed using log-rank methodology and Cox proportional models. Tests for violations of proportionality will performed for the survival models. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.

  2. Time to local progression [ Time Frame: Baseline to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 2.5 years ]
    Data will be summarized by cumulative incidence curves. Fine and Gray models will be used to adjust inference for competing risks. Both unadjusted and adjusted hazard ratios and the respective 95% confidence intervals will be computed.

  3. Proportions of patients with Grade 3 through Grade 5 adverse events that are either related to study drug or not graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 30 days post radiation therapy ]
    Frequencies, proportions and severity of acute adverse events by treatment arm will be presented. Specifically, Grade 3 - 5 adverse events will be tallied. Adverse events related to study drug will also be tallied.

  4. Proportion of undetectable PSA with a non-castrate testosterone [ Time Frame: At 2.5 years post treatment ]
    Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology) and baseline PSA nadir >= 0.2 ng/ml obtained prior to step 1 registration
  • Baseline testosterone level obtained post prostatectomy prior to step 1 registration
  • Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration
  • Primary treatment with radical prostatectomy
  • Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
  • Prior ablative treatment for treatment of benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy (HIFU) prior to prostatectomy is allowed
  • Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration; finasteride or dutasteride must be stopped before treatment but should not determine eligibility; for patients on prior LHRH analogs, the discontinuation date should be calculated based the expected duration of the sustained release injection, not simply the injection date of the drug
  • Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
  • Any pT-stage based on American Joint Committee on Cancer 7th edition is acceptable for study entry based on the following diagnostic workup:

    • History/physical examination within 60 days prior to step 1 registration
    • No distant metastases, based upon the following minimum diagnostic workup:
    • A computed tomography (CT) scan of the abdomen and pelvis (with contrast if renal function is acceptable; a CT without contrast is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; lymph nodes will be non-metastatic unless they measure more than 1.5 cm short axis;
    • Bone scan within 120 days prior to step 1 registration (a sodium fluoride [NaF] positron emission tomography/computed tomography [PET/CT] is an acceptable substitute); if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration
  • Platelets >= 1 X 10^6 cells/mm^3 (100,000) based upon complete blood count (CBC)
  • Hemoglobin >= 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is not allowed)
  • Absolute neutrophil count greater than 1.5 x 10^9/L (1500)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal
  • Total bilirubin normal unless history of Gilbert's syndrome
  • The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
  • Available surgical formalin-fixed paraffin-embedded (FFPE) specimen for genomic analysis on DECIPHER Genomic Resource Information Database (GRID) platform

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years) Ta bladder cancer is not considered invasive
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
  • Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
  • Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
  • Severe and/or active co-morbidity defined as follows:

    • History of inflammatory bowel disease
    • History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration
    • Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
    • Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole, clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine, phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol

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): NCT03070886


Contacts
Layout table for location contacts
Contact: Mark Hurwitz, MD 215-955-5485 mark.hurwitz@jeffersonhospital.org

  Hide Study Locations
Locations
Layout table for location information
United States, Alaska
Fairbanks Memorial Hospital Recruiting
Fairbanks, Alaska, United States, 99701
Contact: Site Public Contact    907-458-3043    cancerresearch@foundationhealth.org   
Principal Investigator: John A. Keech         
United States, Arizona
University of Arizona Cancer Center-Orange Grove Campus Recruiting
Tucson, Arizona, United States, 85704
Contact: Site Public Contact    520-694-8900      
Principal Investigator: Shona T. Dougherty         
University of Arizona Cancer Center-North Campus Recruiting
Tucson, Arizona, United States, 85719
Contact: Site Public Contact    800-327-2873      
Principal Investigator: Shona T. Dougherty         
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Site Public Contact    520-626-9008      
Principal Investigator: Shona T. Dougherty         
United States, Arkansas
Fowler Family Center for Cancer Care Suspended
Jonesboro, Arkansas, United States, 72401
United States, California
Kaiser Permanente-Deer Valley Medical Center Recruiting
Antioch, California, United States, 94531
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Fremont Recruiting
Fremont, California, United States, 94538
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Fresno Cancer Center Recruiting
Fresno, California, United States, 93720
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Fresno Recruiting
Fresno, California, United States, 93720
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
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: Brent S. Rose         
Kaiser Permanente-Modesto Recruiting
Modesto, California, United States, 95356
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente Oakland-Broadway Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Feather River Cancer Center Recruiting
Paradise, California, United States, 95969
Contact: Site Public Contact    530-876-7995    haleew@ah.org   
Principal Investigator: Sam Mazj         
Kaiser Permanente-Rancho Cordova Cancer Center Recruiting
Rancho Cordova, California, United States, 95670
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Richmond Recruiting
Richmond, California, United States, 94801
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Sutter Cancer Centers Radiation Oncology Services-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Site Public Contact    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
The Permanente Medical Group-Roseville Radiation Oncology Recruiting
Roseville, California, United States, 95678
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Site Public Contact    916-454-6500    cancerinfo@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Kaiser Permanente-South Sacramento Recruiting
Sacramento, California, United States, 95823
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
South Sacramento Cancer Center Recruiting
Sacramento, California, United States, 95823
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente - Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Naval Medical Center -San Diego Suspended
San Diego, California, United States, 92134
Kaiser Permanente-San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Santa Teresa-San Jose Recruiting
San Jose, California, United States, 95119
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente San Leandro Recruiting
San Leandro, California, United States, 94577
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-San Rafael Recruiting
San Rafael, California, United States, 94903
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser San Rafael-Gallinas Recruiting
San Rafael, California, United States, 94903
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Santa Rosa Recruiting
Santa Rosa, California, United States, 95403
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente Cancer Treatment Center Recruiting
South San Francisco, California, United States, 94080
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Stockton Recruiting
Stockton, California, United States, 95210
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
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         
Kaiser Permanente Medical Center-Vacaville Recruiting
Vacaville, California, United States, 95688
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Kaiser Permanente-Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
Sutter Solano Medical Center/Cancer Center Recruiting
Vallejo, California, United States, 94589
Contact: Site Public Contact    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Kaiser Permanente-Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Tatjana Kolevska         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    720-848-0650      
Principal Investigator: Elizabeth R. Kessler         
UCHealth Memorial Hospital Central Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Site Public Contact    719-365-2406      
Principal Investigator: Elizabeth R. Kessler         
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Site Public Contact    970-297-6150      
Principal Investigator: Elizabeth R. Kessler         
United States, Delaware
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Site Public Contact    302-645-3100    Dmiskin@Beebehealthcare.org   
Principal Investigator: Gregory A. Masters         
United States, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Recruiting
Coral Gables, Florida, United States, 33146
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Matthew C. Abramowitz         
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Matthew C. Abramowitz         
Florida Hospital Kissimmee Recruiting
Kissimmee, Florida, United States, 34744
Contact: Site Public Contact    407-303-5999      
Principal Investigator: Carlos A. Alemany         
Lakeland Regional Health Hollis Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Site Public Contact    800-517-2234      
Principal Investigator: Madhavi L. Venigalla         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Matthew C. Abramowitz         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Carlos A. Alemany         
United States, Georgia
Grady Health System Active, not recruiting
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown Active, not recruiting
Atlanta, Georgia, United States, 30308
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Site Public Contact    404-425-7943    ORS@piedmont.org   
Principal Investigator: Adam W. Nowlan         
Emory University Hospital/Winship Cancer Institute Active, not recruiting
Atlanta, Georgia, United States, 30322
Emory Saint Joseph's Hospital Active, not recruiting
Atlanta, Georgia, United States, 30342
Piedmont Fayette Hospital Recruiting
Fayetteville, Georgia, United States, 30214
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Adam W. Nowlan         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Howard A. Zaren         
United States, Illinois
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
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         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Elmhurst Memorial Hospital Active, not recruiting
Elmhurst, Illinois, United States, 60126
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
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 Active, not recruiting
Naperville, Illinois, United States, 60540
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
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         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Edward Hospital/Cancer Center?Plainfield Active, not recruiting
Plainfield, Illinois, United States, 60585
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
United States, Indiana
Parkview Hospital Randallia Active, not recruiting
Fort Wayne, Indiana, United States, 46805
Parkview Regional Medical Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Site Public Contact    877-784-4673      
Principal Investigator: Zhentao Zhang         
Goshen Center for Cancer Care Active, not recruiting
Goshen, Indiana, United States, 46526
Indiana University/Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Nabil Adra         
Reid Health Recruiting
Richmond, Indiana, United States, 47374
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
United States, Iowa
McFarland Clinic PC - Ames Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Joseph J. Merchant         
United States, Kansas
University of Kansas Cancer Center Active, not recruiting
Kansas City, Kansas, United States, 66160
Olathe Medical Center Active, not recruiting
Olathe, Kansas, United States, 66061
University of Kansas Cancer Center-Overland Park Active, not recruiting
Overland Park, Kansas, United States, 66210
Cotton O'Neil Cancer Center / Stormont Vail Health Recruiting
Topeka, Kansas, United States, 66606
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Ajay Tejwani         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact    800-362-0070    Keisha.humphries@ascension.org   
Principal Investigator: Pavan S. Reddy         
United States, Louisiana
East Jefferson General Hospital Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact    504-210-3539    trials@jeffradonc.com   
Principal Investigator: Scott E. Delacroix         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Troy G. Scroggins         
United States, Maryland
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Public Contact    800-888-8823      
Principal Investigator: Mark V. Mishra         
Central Maryland Radiation Oncology in Howard County Recruiting
Columbia, Maryland, United States, 21044
Contact: Site Public Contact    443-546-1300      
Principal Investigator: Mark V. Mishra         
Tate Cancer Center Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Site Public Contact    410-553-8100      
Principal Investigator: Mark V. Mishra         
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21801
Contact: Site Public Contact    866-922-6237      
Principal Investigator: John R. Mansueti         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Site Public Contact    617-638-8265      
Principal Investigator: Gretchen A. Gignac         
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Site Public Contact    781-744-8027      
Principal Investigator: Krishna S. Gunturu         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@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: Daniel E. Spratt         
Henry Ford Cancer Institute?Downriver Recruiting
Brownstown, Michigan, United States, 48183
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Eleanor M. Walker         
21st Century Oncology MHP - Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact    248-338-0663      
Principal Investigator: Frank A. Vicini         
McLaren Cancer Institute-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
Henry Ford Macomb Hospital-Clinton Township Recruiting
Clinton Township, Michigan, United States, 48038
Contact: Site Public Contact    313-916-1784      
Principal Investigator: Eleanor M. Walker         
Beaumont Hospital-Dearborn Recruiting
Dearborn, Michigan, United States, 48124
Contact: Site Public Contact    313-593-8090      
Principal Investigator: Zachary A. Seymour         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Site Public Contact    313-916-1784      
Principal Investigator: Eleanor M. Walker         
21st Century Oncology MHP - Farmington Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Site Public Contact    248-338-0663      
Principal Investigator: Frank A. Vicini         
Weisberg Cancer Treatment Center Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
McLaren Cancer Institute-Flint Recruiting
Flint, Michigan, United States, 48532
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
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         
McLaren-Greater Lansing Recruiting
Lansing, Michigan, United States, 48910
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
McLaren Cancer Institute-Lapeer Region Recruiting
Lapeer, Michigan, United States, 48446
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
McLaren Cancer Institute-Macomb Recruiting
Mount Clemens, Michigan, United States, 48043
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
McLaren Cancer Institute-Central Michigan Recruiting
Mount Pleasant, Michigan, United States, 48858
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
McLaren Cancer Institute-Northern Michigan Recruiting
Petoskey, Michigan, United States, 49770
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
21st Century Oncology-Pontiac Recruiting
Pontiac, Michigan, United States, 48341
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
McLaren-Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Kiran Devisetty         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Samir Narayan         
21st Century Oncology MHP - Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Site Public Contact    248-338-0663      
Principal Investigator: Frank A. Vicini         
Henry Ford West Bloomfield Hospital Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Site Public Contact    888-734-5322      
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         
United States, Minnesota
Sanford Joe Lueken Cancer Center Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Site Public Contact    218-333-5000      
Principal Investigator: Preston D. Steen         
Saint Luke's Hospital of Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Steven R. Bonin         
Mayo Clinic Health Systems-Mankato Recruiting
Mankato, Minnesota, United States, 56001
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Bradley J. Stish         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Bradley J. Stish         
Coborn Cancer Center at Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Site Public Contact    877-229-4907    coborncancercenter@centracare.com   
Principal Investigator: Donald J. Jurgens         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Paul W. Sperduto         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact    601-815-6700      
Principal Investigator: John C. Henegan         
United States, Missouri
The University of Kansas Cancer Center-South Active, not recruiting
Kansas City, Missouri, United States, 64131
The University of Kansas Cancer Center-North Active, not recruiting
Kansas City, Missouri, United States, 64154
The University of Kansas Cancer Center-Lee's Summit Active, not recruiting
Lee's Summit, Missouri, United States, 64064
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Site Public Contact    816-271-7937    linda.schumacher@mymlc.com   
Principal Investigator: Jay W. Carlson         
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 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         
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: Benjamin T. Marchello         
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-354-5144      
Principal Investigator: Ralph J. Hauke         
United States, New Hampshire
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         
United States, New Jersey
AtlantiCare Health Park-Cape May Court House Recruiting
Cape May Court House, New Jersey, United States, 08210
Contact: Site Public Contact    888-369-2427      
Principal Investigator: Raghava Reddy Levaka Veera         
AtlantiCare Surgery Center Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Site Public Contact    609-748-7200      
Principal Investigator: Raghava Reddy Levaka Veera         
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: Gurkamal S. Chatta         
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         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Site Public Contact    800-862-2215      
Principal Investigator: Craig E. Grossman         
Dickstein Cancer Treatment Center Suspended
White Plains, New York, United States, 10601
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: William R. Lee         
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Site Public Contact    336-832-0821    vivian.sheidler@conehealth.com   
Principal Investigator: Vinay K. Gudena         
Margaret R Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: Site Public Contact    828-696-4716    karen.morris@unchealth.unc.edu   
Principal Investigator: James E. Radford         
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Site Public Contact    701-323-5760    tamara.fischer@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-234-6161      
Principal Investigator: Preston D. Steen         
United States, Ohio
UHHS-Chagrin Highlands Medical Center Recruiting
Beachwood, Ohio, United States, 44122
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
Geauga Hospital Recruiting
Chardon, Ohio, United States, 44024
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
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         
Mercy Cancer Center-Elyria Recruiting
Elyria, Ohio, United States, 44035
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
Atrium Medical Center-Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
Southwest General Health Center Ireland Cancer Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
University Hospitals Parma Medical Center Recruiting
Parma, Ohio, United States, 44129
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
University Hospitals Portage Medical Center Recruiting
Ravenna, Ohio, United States, 44266
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
Ireland Cancer Center at Firelands Regional Medical Center Recruiting
Sandusky, Ohio, United States, 44870
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
ProMedica Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Abhijit B. Saste         
University of Toledo Active, not recruiting
Toledo, Ohio, United States, 43614
UHHS-Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Christopher J. Hoimes         
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Research Recruiting
Lawton, Oklahoma, United States, 73505
Contact: Site Public Contact    877-231-4440      
Principal Investigator: J. S. Thompson         
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: J. S. Thompson         
United States, Oregon
Clackamas Radiation Oncology Center Active, not recruiting
Clackamas, Oregon, United States, 97015
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center Active, not recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital Active, not recruiting
Abington, Pennsylvania, United States, 19001
Crozer-Keystone Regional Cancer Center at Broomall Recruiting
Broomall, Pennsylvania, United States, 19008
Contact: Site Public Contact    610-284-8237    Jolene.garney@crozer.org   
Principal Investigator: Rachelle M. Lanciano         
Christiana Care Health System-Concord Health Center Recruiting
Chadds Ford, Pennsylvania, United States, 19317
Contact: Site Public Contact    302-623-4450    KDempsey@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: Raghava Reddy Levaka Veera         
Northeast Radiation Oncology Center Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: Site Public Contact    888-808-6762      
Principal Investigator: Mark D. Hurwitz         
Crozer Regional Cancer Center at Brinton Lake Recruiting
Glen Mills, Pennsylvania, United States, 19342
Contact: Site Public Contact    610-284-8237      
Principal Investigator: Rachelle M. Lanciano         
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: Dwight E. Heron         
Jefferson Hospital Recruiting
Jefferson Hills, Pennsylvania, United States, 15025
Contact: Site Public Contact    412-359-3043    ddefazio@wpahs.org   
Principal Investigator: Ralph J. Miller         
Saint Mary Medical and Regional Cancer Center Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Site Public Contact    215-710-4585      
Principal Investigator: Robert E. Reilly         
Geisinger Medical Oncology-Lewisburg Recruiting
Lewisburg, Pennsylvania, United States, 17837
Contact: Site Public Contact    570-374-8555    HemonCCTrials@geisinger.edu   
Principal Investigator: Raghava Reddy Levaka Veera         
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: Site Public Contact    717-242-7703    HemonCCTrials@geisinger.edu   
Principal Investigator: Raghava Reddy Levaka Veera         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Site Public Contact    215-955-6084      
Principal Investigator: Mark D. Hurwitz         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Site Public Contact    215-728-4790      
Principal Investigator: Mark L. Sobczak         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Site Public Contact    215-728-2983      
Principal Investigator: Mark L. Sobczak         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Site Public Contact    877-284-2000      
Principal Investigator: Ralph J. Miller         
Penn State Health Saint Joseph Medical Center Recruiting
Reading, Pennsylvania, United States, 19605
Contact: Site Public Contact    610-378-2336    dward1@pennstatehealth.psu.edu   
Principal Investigator: Navesh K. Sharma         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Site Public Contact    610-988-9323      
Principal Investigator: Terrence P. Cescon         
Wexford Health and Wellness Pavilion Recruiting
Wexford, Pennsylvania, United States, 15090
Contact: Site Public Contact    412-359-3043    ddefazio@wpahs.org   
Principal Investigator: Ralph J. Miller         
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: Raghava Reddy Levaka Veera         
Abington Memorial Hospital-Asplundh Cancer Pavilion Active, not recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Jeremy M. Kilburn         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Self Regional Healthcare Active, not recruiting
Greenwood, South Carolina, United States, 29646
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
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         
The Radiation Oncology Center-Hilton Head/Bluffton Recruiting
Hilton Head Island, South Carolina, United States, 29926
Contact: Site Public Contact    912-819-5704    underberga@sjchs.org   
Principal Investigator: Howard A. Zaren         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
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         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Site Public Contact    888-634-7268    oncregulatory@avera.org   
Principal Investigator: Benjamin M. Solomon         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Preston D. Steen         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Neil B. Desai         
University of Texas Medical Branch Active, not recruiting
Galveston, Texas, United States, 77555-0565
UTMB Cancer Center at Victory Lakes Active, not recruiting
League City, Texas, United States, 77573
United States, Utah
Logan Regional Hospital Recruiting
Logan, Utah, United States, 84321
Contact: Site Public Contact    435-716-6400    officeofresearch@imail.org   
Principal Investigator: R. J. Lee         
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Site Public Contact    801-507-3950    officeofresearch@imail.org   
Principal Investigator: R. J. Lee         
McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Site Public Contact    801-387-7426    officeofresearch@imail.org   
Principal Investigator: R. J. Lee         
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: Site Public Contact    435-688-4167    officeofresearch@imail.org   
Principal Investigator: R. J. Lee         
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: R. J. Lee         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Site Public Contact    801-408-1347    officeofresearch@imail.org   
Principal Investigator: R. J. Lee         
United States, Vermont
Southwestern Vermont Medical Center Recruiting
Bennington, Vermont, United States, 05201
Contact: Site Public Contact    802-447-1836      
Principal Investigator: Alan C. Hartford         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Site Public Contact    434-243-6303    PAS9E@virginia.edu   
Principal Investigator: Timothy N. Showalter         
United States, Washington
MultiCare Auburn Medical Center Recruiting
Auburn, Washington, United States, 98001
Contact: Site Public Contact    253-887-9333    research@multicare.org   
Principal Investigator: John A. Keech         
United States, West Virginia
West Virginia University Charleston Division Recruiting
Charleston, West Virginia, United States, 25304
Contact: Site Public Contact    304-388-9944      
Principal Investigator: Steven J. Jubelirer         
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Site Public Contact    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Malcolm D. Mattes         
Camden Clark Medical Center Recruiting
Parkersburg, West Virginia, United States, 26101
Contact: Site Public Contact    304-424-2585    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Malcolm D. Mattes         
United States, Wisconsin
Aurora Cancer Care-Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Aurora Cancer Care-Kenosha South Recruiting
Kenosha, Wisconsin, United States, 53142
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Aurora Bay Area Medical Group-Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Community Memorial Hospital Recruiting
Menomonee Falls, Wisconsin, United States, 53051
Contact: Site Public Contact    262-257-5100      
Principal Investigator: Colleen A. Lawton         
Columbia Saint Mary's Hospital - Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Craig A. Schulz         
Columbia Saint Mary's Water Tower Medical Commons Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Craig A. Schulz         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Rubina Qamar         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-805-4380      
Principal Investigator: Colleen A. Lawton         
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Zablocki Veterans Administration Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Site Public Contact    888-469-6614      
Principal Investigator: Elizabeth M. Gore         
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Marshfield Clinic-Rice Lake Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Vince Lombardi Cancer Clinic-Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
Marshfield Clinic Stevens Point Center Recruiting
Stevens Point, Wisconsin, United States, 54482
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
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: Rubina Qamar         
Aspirus Regional Cancer Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Site Public Contact    877-405-6866      
Principal Investigator: Christopher S. Platta         
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Rubina Qamar         
The Alyce and Elmore Kraemer Cancer Care Center Recruiting
West Bend, Wisconsin, United States, 53095
Contact: Site Public Contact    866-680-0505      
Principal Investigator: Colleen A. Lawton         
Diagnostic and Treatment Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Site Public Contact    888-799-3989    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Mark Hurwitz, MD NRG Oncology

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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT03070886     History of Changes
Other Study ID Numbers: NRG-GU002
NCI-2016-00963 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GU002
NRG-GU002 ( Other Identifier: NRG Oncology )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Leuprolide
Goserelin
Bicalutamide
Flutamide
Nilutamide
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal