PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer Using Ultrahypofractionated Whole-Pelvis Radiotherapy

What this Trial Is About

This trial studies men with prostate cancer that has spread to pelvic lymph nodes but not to distant sites, identified using PSMA PET imaging. The goal is to compare two radiation dose escalation strategies—focusing on the prostate alone versus both prostate and lymph nodes—to find the best way to control the disease long-term. This phase II/III trial addresses gaps in current treatments by using modern imaging and ultrahypofractionated radiotherapy techniques alongside hormone therapies. Participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy over five sessions combined with long-term androgen deprivation therapy. The study randomly assigns patients to receive either a prostate radiotherapy dose without additional boost or an ablative prostate boost via one of three methods. They also compare two levels of radiation dose to the PSMA PET-positive pelvic lymph nodes. Dose adjustments to protect organs at risk are allowed. Use of androgen receptor pathway inhibitors is permitted according to clinical practice. Throughout the study, participants undergo baseline PSMA PET/CT scans to confirm eligibility and exclude distant metastases. They are monitored regularly for metastasis-free survival up to 10 years, with additional assessments including overall survival, progression-free survival measured by imaging, local and nodal control, time to resistant cancer, treatment toxicity, and quality of life measures. Patient-reported outcomes on urinary, bowel, sexual function, and global health are collected, ensuring comprehensive evaluation of treatment impact and safety over long-term follow-up.

PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer