Neoadjuvant Hormone and Radiation Therapy Followed by Robotic Radical Prostatectomy in Men with High-Risk Locally Advanced Prostate Cancer

What this Trial Is About

Researchers are evaluating treatments for men with high-risk locally advanced prostate cancer, focusing on the effectiveness and safety of neoadjuvant hormone and radiation therapy followed by radical prostatectomy. This two-stage randomized trial compares neoadjuvant hormone therapy combined with radiation therapy against hormone therapy alone before surgery. The study aims to understand if adding radiation therapy before surgery improves outcomes for this condition. Participants are randomly assigned to one of two groups. The first group receives intensity modulated radiation therapy IMRT delivering 50 Gy over 25 daily fractions for 5 weeks, along with hormone therapy using Goserelin 3.6 mg injections at weeks 1, 5, and 9, followed by robotic-assisted radical prostatectomy and pelvic lymph node dissection. The second group receives only the hormone therapy injections at the same schedule before undergoing the prostatectomy. After these interventions, participants are monitored for up to 20 years. During the study, participants will be assessed for the success of salvage radiation therapy by measuring pathologic complete or near-complete response at surgery, PSA decline rates, surgical margin status, and disease staging. Researchers will also track biochemical recurrence-free survival, metastasis-free survival, prostate cancer-specific death, and overall survival over a period of up to 10 years. Follow-up visits will include regular evaluations to monitor these outcomes and ensure safety throughout the long-term study.

Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer