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
SWOG Cancer Research Network
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.
Description
PRIMARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone. SECONDARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor. II. To compare the rate of symptomatic local progression between the treatment arms. III. To compare progression-free surviva…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- 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., brachythe…
Interventions
- DrugAbiraterone
Given PO
- DrugBicalutamide
Given PO
- DrugDegarelix
Given via injection
- DrugDocetaxel
intravenous
- DrugFlutamide
Given PO
- DrugGoserelin Acetate
Given SC
- DrugHistrelin Acetate
Receive SC
- Drug
Locations (338)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Cancer Center at Saint Joseph'sPhoenix, Arizona
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Mayo Clinic in ArizonaScottsdale, Arizona
- University of Arizona Cancer Center-Orange Grove CampusTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona