Phase II Trial of FDG-PET-Guided Radiation Therapy plus Standard Treatment for Men with Metastatic Hormone Sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating the use of FDG-positron emission tomography PET-guided metastasis directed radiation therapy MDRT combined with standard treatments compared to standard treatments alone for men with metastatic hormone sensitive prostate cancer. This phase II trial focuses on patients whose prostate cancer has spread beyond the original site and remains sensitive to androgen deprivation therapy ADT. The study aims to see if this combined approach can improve progression-free survival and the complete response rate in different patient groups based on their treatment status. Participants are divided into two cohorts Cohort 1 includes patients undergoing cytotoxic chemotherapy plus ADT, while Cohort 2 includes those receiving ADT without cytotoxic chemotherapy. After six months of standard care, patients receive an FDG-PET scan to detect active cancer sites. Those with PET-avid disease are randomized to receive either MDRT plus standard care or standard care alone, with MDRT targeting up to 5 disease sites if no unacceptable toxicity occurs. Patients without PET-avid disease continue standard care. Throughout the trial, participants undergo CT scans, bone scans, and additional FDG-PET scans as applicable. Participants will be monitored regularly with imaging and lab tests, including prostate-specific antigen PSA levels, to measure cancer progression and response. Follow-up visits occur at 3 and 6 months after treatment completion, then every 6 months up to 36 months. Researchers evaluate progression-free survival, radiographic progression, PSA levels, skeletal events, response rates on imaging, and safety of MDRT. The study lasts up to three years, allowing detailed assessment of treatment effects and side effects over time.

FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial