Phase III Study Comparing 5-Session Prostate-Only SBRT to Prostate and Pelvic Nodal SBRT in Men with High Risk Localized Prostate Cancer

What this Trial Is About

Researchers are evaluating two types of stereotactic body radiotherapy SBRT in men with high risk localized prostate cancer, where the cancer is confined to the prostate but may grow quickly or spread. The study aims to compare the safety and effectiveness of delivering radiotherapy to the prostate alone versus the prostate plus surrounding lymph nodes, with both treatments given in only 5 sessions. This phase III trial is designed to see if including lymph nodes reduces the chance of cancer returning and to review any side effects that occur. Participants will be randomly assigned to one of two groups. One group will receive SBRT targeting the prostate and seminal vesicles, delivering 36.25Gy in 5 fractions on alternate days with 40Gy to the prostate clinical target volume. The other group will get the same prostate treatment plus 25Gy in 5 fractions to the pelvic lymph nodes on alternate days. Treatments will be provided over approximately two weeks at experienced NHS radiotherapy centers that meet quality standards for these therapies. During the study, participants will be monitored for at least three and a half years to assess time to biochemical or clinical failure, which is the main outcome. Researchers will also track acute and late side effects, cancer relapse, survival rates, patient-reported outcomes, and adherence to treatment protocols for up to five years post-randomization. Regular imaging and assessments will be performed before treatment to confirm eligibility and exclude metastatic disease. Overall, participants can expect close monitoring and follow-up throughout and after their treatment period.

A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT