Clinical trial Recruiting at 297 sites Phase 3 Interventional Ages 18 and up Men only

Comparing standard therapy with or without surgery or radiation for metastatic prostate cancer

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

Run by SWOG Cancer Research Network · NCT03678025 · Data updated 2026-11-12

This study is testing whether adding surgery or radiation to standard treatment helps men with metastatic prostate cancer live longer and feel better compared to just standard treatment alone.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment1273 (estimated)
SponsorSWOG Cancer Research Network
Research network
Drugs / interventionsradiation, prednisone
Locations338 sites (Gilbert, Arizona and 337 other locations)
StatusRecruiting
StartedSeptember 24, 2018
Main results expectedApril 1, 2033
Study endsOctober 1, 2036
Registry record updatedOctober 8, 2026
Trial IDNCT03678025 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with histologically confirmed metastatic adenocarcinoma of the prostate who have not undergone prior local therapy.

Probably not a fit

Patients with small cell carcinoma or those who have previously received local therapy for prostate adenocarcinoma may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial investigates the effectiveness of standard systemic therapy combined with definitive treatment, such as prostate removal surgery or radiation therapy, in patients with metastatic prostate cancer. The study aims to compare overall survival rates between patients receiving standard therapy alone and those receiving it alongside definitive treatment. Secondary objectives include assessing local progression rates, progression-free survival, and quality of life metrics over time. Additionally, tissue and blood specimens will be collected for future research.

Why it matters

Potential benefit: If successful, this study could improve survival rates and quality of life for patients with metastatic prostate cancer.

How similar studies have gone: Other studies have shown promising results with similar approaches, indicating potential for significant advancements in treatment.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Banner MD Anderson Cancer Center
    Gilbert, Arizona, United States
    Recruiting
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona, United States
    Recruiting
  • University of Arizona Cancer Center-Orange Grove Campus
    Tucson, Arizona, United States
    Recruiting
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona, United States
    Recruiting
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States
    Recruiting
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California, United States
    Recruiting
Show 44 more locations
  • Community Cancer Institute
    Clovis, California, United States
    Recruiting
  • City of Hope Comprehensive Cancer Center
    Duarte, California, United States
    Recruiting
  • Kaiser Permanente Dublin
    Dublin, California, United States
    Recruiting
  • Kaiser Permanente-Fremont
    Fremont, California, United States
    Recruiting
  • Fresno Cancer Center
    Fresno, California, United States
    Recruiting
  • Kaiser Permanente-Fresno
    Fresno, California, United States
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • Tibor Rubin VA Medical Center
    Long Beach, California, United States
    Recruiting
  • Los Angeles County-USC Medical Center
    Los Angeles, California, United States
    Recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting
  • Fremont - Rideout Cancer Center
    Marysville, California, United States
    Recruiting
  • Kaiser Permanente-Modesto
    Modesto, California, United States
    Recruiting
  • Kaiser Permanente Oakland-Broadway
    Oakland, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • Desert Regional Medical Center
    Palm Springs, California, United States
    Recruiting
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California, United States
    Recruiting
  • Kaiser Permanente-Rancho Cordova Cancer Center
    Rancho Cordova, California, United States
    Recruiting
  • Kaiser Permanente-Redwood City
    Redwood City, California, United States
    Recruiting
  • Kaiser Permanente-Richmond
    Richmond, California, United States
    Recruiting
  • Rohnert Park Cancer Center
    Rohnert Park, California, United States
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California, United States
    Recruiting
  • The Permanente Medical Group-Roseville Radiation Oncology
    Roseville, California, United States
    Recruiting
  • Kaiser Permanente Downtown Commons
    Sacramento, California, United States
    Recruiting
  • Mercy Cancer Center - Sacramento
    Sacramento, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-South Sacramento
    Sacramento, California, United States
    Recruiting
  • South Sacramento Cancer Center
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-San Francisco
    San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, United States
    Recruiting
  • Kaiser Permanente San Leandro
    San Leandro, California, United States
    Recruiting
  • Pacific Central Coast Health Center-San Luis Obispo
    San Luis Obispo, California, United States
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California, United States
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, United States
    Recruiting
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Kaiser Permanente Cancer Treatment Center
    South San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Stockton
    Stockton, California, United States
    Recruiting
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
    Truckee, California, United States
    Recruiting
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California, United States
    Recruiting
  • Kaiser Permanente-Vallejo
    Vallejo, California, United States
    Recruiting
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, United States
    Recruiting
  • University of Colorado Hospital
    Aurora, Colorado, United States
    Recruiting
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado, United States
    Recruiting
  • UCHealth Memorial Hospital Central
    Colorado Springs, Colorado, United States
    Recruiting

+288 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Brian Chapin — SWOG Cancer Research Network
  • Study coordinator: Dana Sparks, MAT
  • Email: dsparks@swog.org
  • Phone: 2106148808

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.