STAMPEDE2 Trial Testing New Radiation and Drug Treatments Alongside Standard Therapy for Men with Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating two new treatments compared to the best standard care for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This phase 3 trial includes multiple hospitals across the UK and is led by University College London. The study aims to see if adding targeted radiotherapy or a radioactive drug can slow cancer spread and improve survival. Participants are assigned by computer to one of several groups. One group receives standard care, which includes androgen deprivation therapy ADT plus other hormone therapies, possible chemotherapy with docetaxel, and local radiotherapy. Another group receives standard care plus targeted high-dose radiotherapy SABR to metastatic sites. A third group receives standard care plus a radioactive therapy called 177Lu-PSMA-617, given in cycles with two doses per cycle. Treatments continue unless side effects are severe or participants choose to stop. During the study, participants will have scans and tests to monitor their cancer and side effects. Doctors will check safety and treatment adherence over time. Researchers will measure overall survival, failure-free survival, progression-free survival, prostate cancer-specific survival, and quality of life up to 10 years from randomization. Safety will be closely monitored, and participants health will be followed during and after treatment.

A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer