PRO-BOOST-N Phase IIIII Trial Testing Prostate and Pelvic Lymph Node Radiation Dose Escalation in Node-Positive Prostate Cancer Using Ultrahypofractionated Radiotherapy

What this Trial Is About

Researchers are investigating the best way to intensify radiotherapy for patients with prostate cancer that has spread to pelvic lymph nodes but not to distant sites. This trial focuses on patients confirmed by PSMA PETCT imaging to have node-positive prostate cancer without distant metastases. The study seeks to determine if increasing the radiation dose to the prostate, the pelvic lymph nodes, or both improves long-term outcomes, including preventing the spread of cancer and enhancing survival. Participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy regimen delivered in five treatments, combined with long-term androgen deprivation therapy, with optional androgen receptor pathway inhibitors. The trial uses a 2 x 2 factorial design to compare four groups prostate radiotherapy without additional boost with intermediate or higher nodal radiation doses, and prostate radiotherapy with an additional ablative prostate boost using high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost combined with either intermediate or higher nodal doses. The boost technique is assigned based on availability and suitability per participant. Throughout the study, participants undergo clinical assessments, PSA and testosterone monitoring, toxicity reporting, and patient-reported quality of life evaluations focused on urinary, bowel, sexual, and global health domains. Imaging with PSMA PET is used at baseline and upon suspected progression to assess disease status. The main outcome measured is metastasis-free survival over up to 10 years, with additional outcomes including overall survival, progression-free survival, local and nodal control, time to castration-resistant cancer, treatment side effects, and quality of life. The study includes long-term follow-up to capture late events and treatment effects.

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