Phase 3 Study Comparing Standard Systemic Therapy Alone Versus With Surgery or Radiation for Metastatic Prostate Cancer

What this Trial Is About

Researchers are investigating how well standard systemic therapy, with or without additional definitive treatment such as prostate removal surgery or radiation therapy, works in treating men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and progression outcomes between patients receiving systemic therapy alone and those receiving systemic therapy plus definitive treatment of the primary tumor. The study also examines quality of life factors, including urinary function, pain, and physical functioning. Participants first receive one of six acceptable forms of standard systemic therapy for 22 to 28 weeks, which may include hormonal therapies, oral medications, injections, or chemotherapy drugs like docetaxel. After this induction period, participants are randomly assigned to continue standard systemic therapy alone or to receive systemic therapy plus prostatectomy or radiation therapy within a specific timeframe. Following treatment, participants are monitored and followed up for up to eight years. During the study, participants undergo various assessments including physical exams, laboratory tests for prostate-specific antigen PSA and testosterone levels, and imaging scans to monitor disease progression. Patient-reported outcomes related to urinary symptoms, pain, and quality of life are collected at multiple time points up to three years. The main outcome measured is overall survival over an eight-year period. Researchers also bank tissue and blood samples for future studies and observe safety and disease progression throughout the follow-up period.

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer