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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1273 (estimated) |
| Sponsor | SWOG Cancer Research Network Research network |
| Drugs / interventions | radiation, prednisone |
| Locations | 338 sites (Gilbert, Arizona and 337 other locations) |
| Status | Recruiting |
| Started | September 24, 2018 |
| Main results expected | April 1, 2033 |
| Study ends | October 1, 2036 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT03678025 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.
-
Using abemaciclib before a radioactive treatment for advanced prostate cancer
This study is testing if taking abemaciclib before a radioactive treatment can help men with advanced prostate cancer feel better and improve their treatment results.
-
Exercise and Fitbit monitoring for prostate cancer patients on hormone therapy
This study tests if a 16-week exercise program with Fitbit tracking can help prostate cancer patients on hormone therapy improve their heart health and manage other related health risks.
-
Combining talazoparib with hormone therapy and abiraterone for prostate cancer treatment
This study is testing if adding a new drug called talazoparib to standard hormone therapy and abiraterone can help men with advanced prostate cancer do better with their treatment.
-
Combining cryoablation and radiation therapy for painful bone metastases
This study is testing if combining a freezing treatment with radiation can help people with painful bone cancer feel better compared to just using radiation alone.
-
Using image-guided biopsies to understand resistance in advanced prostate cancer treatment
This study is testing how advanced imaging can help doctors understand why some men with hard-to-treat prostate cancer don't respond to a specific therapy, so they can find better treatment options.
-
Measuring ctDNA to guide stopping 177Lu-PSMA-617 in metastatic prostate cancer
This trial tests whether ctDNA tumor fraction can help decide when to stop 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.