Randomized Phase III Study of Optimal Sequencing of Hormonal Therapy and Radiation in Patients with T1-T3 Prostate Cancer

Official Title

A Randomized Phase III Trial of Optimal Sequencing of Hormone Therapy and Radiation Therapy in Patients with T1-T3 Prostate Cancer

Summary:

The study is designed to evaluate the optimal sequencing of radiation therapy and hormonal therapy in the treatment of patients with carcinoma of the prostate. Patients with cT1-T3N0M0 prostate cancer will be randomized to early versus delayed radiation therapy regimen in combination with 6 months of hormonal therapy.  The main objective of this trial is to assess the optimal timing of radiation therapy on various clinical outcomes. 

Trial Description

Primary Outcome

• PSA relapse free survival

Secondary Outcome

• Overall survival
• Local control rate at 2 years post completion of therapy
• Quality of Life as measured by the EORTC QLQ–C30 and PR-25 questionnaire.
• Treatment toxicity (RTOG Toxicity Scale including Fox Chase modifications).