Single-Dose Image-Guided Radiotherapy With Targeted Boost for Intermediate and High-Risk Prostate Cancer

What this Trial Is About

Researchers are evaluating a new approach to treat intermediate unfavorable and selected high-risk prostate cancer patients using Single Dose Radiation Therapy SDRT with a focal boost to the MRI-defined tumor area. This phase II trial focuses on acute genitourinary toxicity as the primary outcome, comparing the safety and side effects of this single-dose treatment to a five-dose stereotactic body radiotherapy SBRT regimen. The study aims to determine if the shorter treatment can achieve similar toxicity levels and is suitable for further research. Participants are randomly assigned to one of two treatment groups. One group receives 36.25 Gy SBRT delivered in five fractions over two weeks, while the other receives a single 24 Gy SDRT dose with urethra-sparing and a focal boost up to 27 Gy. Both treatments utilize advanced image-guided volumetric intensity-modulated arc radiotherapy IGRT-VMAT with precise planning and continuous motion monitoring using real-time tracking systems. Bladder and rectal preparation protocols differ between groups to optimize treatment delivery and protect surrounding tissues. During the study, participants undergo non-contrast CT and multiparametric MRI scans for treatment planning, with various organs at risk carefully outlined to minimize exposure. Researchers monitor acute and late genitourinary and gastrointestinal side effects over several years, along with quality of life, urinary symptoms, erectile function, and biochemical relapse using standardized questionnaires and PSA testing. The trial includes close safety monitoring with interim analyses and follow-up assessments at 3 months, 1, 2, and 5 years post-treatment, with total participation lasting several years.

ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0