S1802: 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

Primary Objective

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.

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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 survival (PFS) between the two treatment arms. IV. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Cherry Creek Medical Center
Greeley Campus
Harmony Campus
Lone Tree Medical Center
Medical Center of the Rockies
Memorial Hospital Central
Memorial Hospital North
Poudre Valley Hospital
University of Colorado Hospital

Principal Investigator
Photograph of Paul Maroni

Paul Maroni

Study ID

Protocol Number: 18-2252

More information available at ClinicalTrials.gov: NCT03678025

Categories

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