Tri-Modality therapy with I-125 brachytherapy external beam radiation therapy and short- or long-term hormone therapy for high-risk localized prostate cancer (TRIP): study protocol for a phase III multicenter randomized controlled trial

摘要

BackgroundPatients with high Gleason score, elevated prostate specific antigen (PSA) level, and advanced clinical stage are at increased risk for both local and systemic relapse. Recent data suggests higher radiation doses decrease local recurrence and may ultimately benefit biochemical, metastasis-free and disease-specific survival. No randomized data is available on the benefits of long-term hormonal therapy (HT) in these patients. A prospective study on the efficacy and safety of trimodality treatment consisting of HT, external beam radiation therapy (EBRT), and brachytherapy (BT) for high-risk prostate cancer (PCa) is strongly required.