Particle Therapy 2017

PCG GU 002-10 A Phase III Prospective Randomized Trial of Standard-fractionation versus Hypo-fractionation for low-risk Adenocarcinoma of the Prostate PI’s: Carlos Vargas,

Patient Population: Adenocarcinoma of the prostate with low or intermediate risk features including ≤ T2a, Gleason score ≤ 6, and a PSA < 10 ng/ml. Primary Objective If hypo-fractionation will result in freedom from failure (FFF) equivalent to standard fractionation. FFF = first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) Secondary Objectives 1 Incidence of grade > 2 GU and GI toxicity in each arm at 6 months, 2 years and estimate at 3 years. 2. Quality of life issues following completion of radiation therapy at 6 months and at 2-years. Required Sample Size: 448