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Trial record 1 of 1 for:    S1802
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Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

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: NCT03678025
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Condition or disease Intervention/treatment Phase
Castration Levels of Testosterone Metastatic Prostatic Adenocarcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Drug: Abiraterone Drug: Bicalutamide Drug: Degarelix Drug: Docetaxel Drug: Flutamide Drug: Goserelin Acetate Drug: Histrelin Acetate Drug: Leuprolide Acetate Drug: Nilutamide Procedure: Orchiectomy Drug: Prednisone Other: Quality-of-Life Assessment Radiation: Radiation Therapy Procedure: Radical Prostatectomy Drug: Triptorelin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : April 1, 2028
Estimated Study Completion Date : October 1, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Arm I (SST)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
Drug: Abiraterone
Given PO
Other Name: CB 7598

Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Drug: Degarelix
Given via injection
Other Names:
  • FE200486
  • Firmagon

Drug: Flutamide
Given PO
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
Given SC
Other Names:
  • ZDX
  • Zoladex

Drug: Histrelin Acetate
Receive SC
Other Names:
  • Supprelin
  • Vantas

Drug: Leuprolide Acetate
Receive SC or IM
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
Given PO
Other Names:
  • Anandron
  • Nilandron
  • RU-23908

Procedure: Orchiectomy
Undergo bilateral orchiectomy
Other Names:
  • Castration
  • Male Castration
  • Male Gonadectomy
  • orchidectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Triptorelin
injection
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Decapeptyl
  • Detryptoreline

Experimental: Arm II (SST, prostatectomy or radiation therapy)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
Drug: Abiraterone
Given PO
Other Name: CB 7598

Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Drug: Degarelix
Given via injection
Other Names:
  • FE200486
  • Firmagon

Drug: Flutamide
Given PO
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
Given SC
Other Names:
  • ZDX
  • Zoladex

Drug: Histrelin Acetate
Receive SC
Other Names:
  • Supprelin
  • Vantas

Drug: Leuprolide Acetate
Receive SC or IM
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
Given PO
Other Names:
  • Anandron
  • Nilandron
  • RU-23908

Procedure: Orchiectomy
Undergo bilateral orchiectomy
Other Names:
  • Castration
  • Male Castration
  • Male Gonadectomy
  • orchidectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
Standard radiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Procedure: Radical Prostatectomy
Standard surgery
Other Name: Prostatovesiculectomy

Drug: Triptorelin
injection
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Decapeptyl
  • Detryptoreline

Active Comparator: Step 1 (pre-randomization)
Standard treatment data collection prior to randomization
Drug: Abiraterone
Given PO
Other Name: CB 7598

Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Drug: Degarelix
Given via injection
Other Names:
  • FE200486
  • Firmagon

Drug: Docetaxel
intravenous
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Drug: Flutamide
Given PO
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
Given SC
Other Names:
  • ZDX
  • Zoladex

Drug: Histrelin Acetate
Receive SC
Other Names:
  • Supprelin
  • Vantas

Drug: Leuprolide Acetate
Receive SC or IM
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
Given PO
Other Names:
  • Anandron
  • Nilandron
  • RU-23908

Procedure: Orchiectomy
Undergo bilateral orchiectomy
Other Names:
  • Castration
  • Male Castration
  • Male Gonadectomy
  • orchidectomy

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisonum
  • Prednitone
  • Promifen
  • Servisone
  • SK-Prednisone

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Triptorelin
injection
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Decapeptyl
  • Detryptoreline




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years ]

Secondary Outcome Measures :
  1. Media OS [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years ]
    Will compare OS in metastatic prostate cancer patients who received standard systemic therapy (SST) plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.

  2. Rate of symptomatic local progression [ Time Frame: Up to 8 years ]
    Defined as any of the following events post-randomization: Common Terminology Criteria for Adverse Events version 5 grade >= 2 hematuria, urinary retention, urinary tract obstruction, urinary tract pain, pelvic pain, renal and urinary disorders-other. Will be compared between the treatment arms. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

  3. Progression-free survival (PFS) [ Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years ]
    Will be compared between for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.



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:

  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride [NaF], prostate-specific membrane antigen [PSMA], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
  • STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
  • STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=< 4 sites). All treatment must be completed prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.

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): NCT03678025


Contacts
Layout table for location contacts
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Show 140 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brian Chapin Southwest Oncology Group

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT03678025     History of Changes
Other Study ID Numbers: S1802
NCI-2018-01738 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1802 ( Other Identifier: SWOG )
S1802 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Prednisone
Cortisone
Docetaxel
Leuprolide
Goserelin
Bicalutamide
Triptorelin Pamoate
Flutamide
Nilutamide
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs