Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Recruiting · NCT03678025 · Interventional (participants receive a specific treatment) · Lead sponsor: SWOG Cancer Research Network
View the official record on ClinicalTrials.gov →Interventions studied
AbirateroneBicalutamideDegarelixDocetaxelFlutamideGoserelin AcetateHistrelin AcetateLeuprolide AcetateNilutamideOrchiectomyPrednisoneQuality-of-Life AssessmentRadiation TherapyRadical ProstatectomyTriptorelin
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
60 locations listed across 43 US states.
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Cancer Center at Saint Joseph's - Phoenix, Arizona, United States
- Mayo Clinic Hospital in Arizona - Phoenix, Arizona, United States
- Mayo Clinic in Arizona - Scottsdale, Arizona, United States
- University of Arizona Cancer Center-Orange Grove Campus - Tucson, Arizona, United States
- University of Arizona Cancer Center-North Campus - Tucson, Arizona, United States
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
- Kaiser Permanente-Deer Valley Medical Center - Antioch, California, United States
- Community Cancer Institute - Clovis, California, United States
- University Oncology Associates - Clovis, California, United States
- City of Hope Comprehensive Cancer Center - Duarte, California, United States
- Kaiser Permanente Dublin - Dublin, California, United States
- Kaiser Permanente-Fremont - Fremont, California, United States
- Fresno Cancer Center - Fresno, California, United States
- Kaiser Permanente-Fresno - Fresno, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Tibor Rubin VA Medical Center - Long Beach, California, United States
- Los Angeles County-USC Medical Center - Los Angeles, California, United States
- USC / Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Fremont - Rideout Cancer Center - Marysville, California, United States
- Kaiser Permanente-Modesto - Modesto, California, United States
- Kaiser Permanente Oakland-Broadway - Oakland, California, United States
- Kaiser Permanente-Oakland - Oakland, California, United States
- Desert Regional Medical Center - Palm Springs, California, United States
- Stanford Cancer Institute Palo Alto - Palo Alto, California, United States
- Kaiser Permanente-Rancho Cordova Cancer Center - Rancho Cordova, California, United States
- Kaiser Permanente-Redwood City - Redwood City, California, United States
- Kaiser Permanente-Richmond - Richmond, California, United States
- Rohnert Park Cancer Center - Rohnert Park, California, United States
- Kaiser Permanente-Roseville - Roseville, California, United States
- The Permanente Medical Group-Roseville Radiation Oncology - Roseville, California, United States
- Kaiser Permanente Downtown Commons - Sacramento, California, United States
- Mercy Cancer Center - Sacramento - Sacramento, California, United States
- University of California Davis Comprehensive Cancer Center - Sacramento, California, United States
- Kaiser Permanente-South Sacramento - Sacramento, California, United States
- South Sacramento Cancer Center - Sacramento, California, United States
- Kaiser Permanente-San Francisco - San Francisco, California, United States
- Kaiser Permanente-Santa Teresa-San Jose - San Jose, California, United States
- Kaiser Permanente San Leandro - San Leandro, California, United States
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo, California, United States
- Kaiser San Rafael-Gallinas - San Rafael, California, United States
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara, California, United States
- Kaiser Permanente-Santa Rosa - Santa Rosa, California, United States
- Kaiser Permanente Cancer Treatment Center - South San Francisco, California, United States
- Kaiser Permanente-South San Francisco - South San Francisco, California, United States
- Kaiser Permanente-Stockton - Stockton, California, United States
- Gene Upshaw Memorial Tahoe Forest Cancer Center - Truckee, California, United States
- Kaiser Permanente Medical Center-Vacaville - Vacaville, California, United States
- Kaiser Permanente-Vallejo - Vallejo, California, United States
- Kaiser Permanente-Walnut Creek - Walnut Creek, California, United States
- University of Colorado Hospital - Aurora, Colorado, United States
- Rocky Mountain Cancer Centers-Boulder - Boulder, Colorado, United States
- UCHealth Memorial Hospital Central - Colorado Springs, Colorado, United States
- Memorial Hospital North - Colorado Springs, Colorado, United States
- Porter Adventist Hospital - Denver, Colorado, United States
- Shaw Cancer Center - Edwards, Colorado, United States
- Poudre Valley Hospital - Fort Collins, Colorado, United States
- North Colorado Medical Center - Greeley, Colorado, United States
- Littleton Adventist Hospital - Littleton, Colorado, United States
- McKee Medical Center - Loveland, Colorado, United States
Showing 60 of 338 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →