Phase III Study Comparing Image Guided Radiation Therapy Alone Versus Radiation Plus Androgen Suppression in Men with Intermediate Risk Prostate Cancer

What this Trial Is About

Researchers are evaluating two treatment approaches for men with intermediate risk prostate cancer that is localized. This study compares the effects, both positive and negative, of hypofractionated proton radiation therapy alone versus proton therapy combined with androgen suppression therapy. The goal is to better understand the benefits and risks of adding hormone therapy to radiation in this patient group. Participants receive one of two treatments either proton radiation therapy alone given in 28 treatments totaling 70 Gy over 5.5 to 6.5 weeks, high dose radiation with IMRT alone at 81 Gy over 9 to 10 weeks, or intraoperative LDR brachytherapy combined with IMRT totaling 45 Gy. The other group receives androgen suppression therapy for about 6 months starting 8 to 10 weeks before radiation, combined with radiation therapy. The androgen suppression uses FDA-approved LHRH agonists. Treatment schedules and doses are carefully monitored. Throughout the study, participants undergo regular evaluations including toxicity assessments for urinary and gastrointestinal side effects at 6 months and 3 years, quality of life measures, and long-term outcomes such as biochemical failure and survival over 5 years. Researchers also correlate pathology, imaging, and hormone levels with outcomes. Monitoring for treatment-related side effects continues yearly after initial follow-up. Participants are closely followed to assess safety and effectiveness of each treatment approach.

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer