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Clinical Trials in Mexico / NCT03678025
Recruiting Phase 3

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

NCT03678025 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2018-09-24
Last updated
2025-09-11

Condition(s) studied

Castration Levels of TestosteroneMetastatic Prostatic AdenocarcinomaStage IV Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8

Investigational drug(s) / intervention(s)

Abiraterone →Bicalutamide →Degarelix →Docetaxel →Flutamide →Goserelin Acetate →Histrelin AcetateLeuprolide Acetate →NilutamideOrchiectomyPrednisone →Quality-of-Life AssessmentRadiation TherapyRadical ProstatectomyTriptorelin →

Abiraterone: Given PO

Bicalutamide: Given PO

Degarelix: Given via injection

Docetaxel: intravenous

Flutamide: Given PO

Goserelin Acetate: Given SC

Histrelin Acetate: Receive SC

Leuprolide Acetate: Receive SC or IM

Nilutamide: Given PO

Orchiectomy: Undergo bilateral orchiectomy

Prednisone: Given PO

Quality-of-Life Assessment: Ancillary studies

Radiation Therapy: Standard radiation

Radical Prostatectomy: Standard surgery

Triptorelin: injection

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (338)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
Mayo Clinic Hospital in Arizona Phoenix Arizona Suspended
Mayo Clinic in Arizona Scottsdale Arizona Suspended
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Community Cancer Institute Clovis California Recruiting
University Oncology Associates Clovis California Suspended
City of Hope Comprehensive Cancer Center Duarte California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Fresno Cancer Center Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
Tibor Rubin VA Medical Center Long Beach California Recruiting
Los Angeles County-USC Medical Center Los Angeles California Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Recruiting
Fremont - Rideout Cancer Center Marysville California Recruiting
Kaiser Permanente-Modesto Modesto California Recruiting
Kaiser Permanente Oakland-Broadway Oakland California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
Desert Regional Medical Center Palm Springs California Recruiting
Stanford Cancer Institute Palo Alto Palo Alto California Recruiting
Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California Recruiting
Kaiser Permanente-Redwood City Redwood City California Recruiting
Kaiser Permanente-Richmond Richmond California Recruiting
Rohnert Park Cancer Center Rohnert Park California Recruiting
Kaiser Permanente-Roseville Roseville California Recruiting
The Permanente Medical Group-Roseville Radiation Oncology Roseville California Recruiting
Kaiser Permanente Downtown Commons Sacramento California Recruiting
Mercy Cancer Center - Sacramento Sacramento California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
Kaiser Permanente-South Sacramento Sacramento California Recruiting
South Sacramento Cancer Center Sacramento California Recruiting
Kaiser Permanente-San Francisco San Francisco California Recruiting
Kaiser Permanente-Santa Teresa-San Jose San Jose California Recruiting
Kaiser Permanente San Leandro San Leandro California Recruiting
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California Recruiting

+ 298 more sites — see the full list on the official registry below.

On this site

📄 Zytiga (abiraterone) drug profile → 📄 Deltasone (prednisone) drug profile →

More SWOG Cancer Research Network trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03678025 on ClinicalTrials.gov ↗ ← All trials in Mexico