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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