Comparing Androgen Deprivation Therapy With and Without Pelvic Radiotherapy After Prostatectomy in Men with Node Positive Prostate Cancer A Phase 3 Randomized Trial to Assess Disease Control and Survival

What this Trial Is About

Researchers are evaluating whether adding pelvic radiotherapy to androgen deprivation therapy ADT can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive prostate cancer after radical prostatectomy. This Phase 3 trial compares combined ADT and pelvic radiotherapy to ADT alone to determine if the addition of radiotherapy improves biochemical recurrence-free survival, clinical progression-free survival, metastasis-free survival, overall survival, and prostate cancer-specific survival without unacceptable side effects. Participants are randomly assigned in a 21 ratio to one of two groups one receiving pelvic radiotherapy plus ADT, and the other receiving ADT alone. ADT, including GnRH agonists and antagonists such as Triptorelin, Leuprolide, Goserelin, and Degarelix, is given for two years. Radiotherapy is delivered using IMRT or VMAT techniques targeting pelvic lymph node drainage areas and the prostate bed for those with certain pathological features. Patients with radiologically detected pelvic recurrence or distant metastases after prostatectomy are excluded. During the study, participants undergo regular assessments of safety, adverse events, and health-related quality of life. Researchers measure biochemical progression-free survival over five years as the primary outcome, alongside secondary outcomes including clinical recurrence-free survival, metastasis-free survival, overall survival, and quality of life measures. The total study duration extends to the end of 2038, with follow-up visits to monitor disease status and treatment effects.

Radiotherapy After Prostatectomy for Node Positive Prostate Cancer