S1802: Prostate Cancer Therapy Outcomes

DESCRIPTION: 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.

OBJECTIVE: The primary objective is 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.

Treatment: Active Comparator: Arm I (SST): Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Experimental: Arm II (SST, prostatectomy or radiation therapy): Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization. Active Comparator: Step 1 (pre-randomization): Standard treatment data collection prior to randomization

https://www.swog.org/sites/default/files/pdf/S1802_PtMat_Patient-FriendlySummary_060724.pdf

https://clinicaltrials.gov/study/NCT03678025

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AZURE-Outcomes