PRO-BOOST-LC A Phase IIIII Trial Comparing Whole-Gland Prostate Boost Techniques Using HDR or LDR Brachytherapy or SBRT Boost Versus SBRT Monotherapy in Men With Localized or Locally Advanced Prostate Cancer Staged by PSMA PETCT

What this Trial Is About

Researchers are investigating different radiotherapy dose-escalation strategies for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using PSMA PETCT imaging. The study evaluates whether adding a whole-gland prostate boost after external beam radiotherapy improves failure-free survival compared to stereotactic body radiotherapy SBRT monotherapy. This phase IIIII trial aims to clarify the best approach for balancing cancer control, treatment-related toxicity, and quality of life using modern imaging and treatment techniques. Participants are randomly assigned to receive one of four treatments SBRT monotherapy as a control, or external beam radiotherapy EBRT followed by one of three boost strategieshigh-dose-rate HDR brachytherapy, low-dose-rate LDR brachytherapy, or a single-fraction SBRT boost. The EBRT backbone involves five high-dose fractions with advanced image guidance. Boost treatments differ by modality, with HDR delivered via catheter implantation, LDR via permanent seed implantation, and SBRT boost delivered non-invasively. Androgen deprivation therapy ADT may be given based on risk group following current guidelines. Throughout the study, participants undergo baseline evaluations including PSA testing, prostate MRI, and PSMA PETCT imaging. Follow-up includes regular clinical assessments, PSA tests, toxicity evaluations, patient-reported quality-of-life questionnaires, and imaging as needed. Researchers measure failure-free survival, metastasis-free survival, treatment toxicity, and quality of life up to 10 years. Adverse events are monitored closely, and data safety is reviewed regularly to ensure participant safety during this long-term study.

PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer