PROFIT (Prostate Fractionated Irradiation Trial)

PROFIT randomised 1,206 men with intermediate-risk prostate cancer, defined as T1 to T2a with Gleason 6 and PSA 10.1 to 20, or T2b to T2c with Gleason 6 and PSA 20 or less, or T1 to T2 with Gleason 7 and PSA 20 or less, to conventional radiotherapy of 78 Gy in 39 fractions over 8 weeks or hypofractionated radiotherapy of 60 Gy in 20 fractions over 4 weeks. Androgen deprivation was not permitted, which makes PROFIT a clean test of the radiation schedule alone.

The primary outcome, biochemical or clinical failure, was defined as PSA failure at nadir plus 2, hormonal intervention, local or distant clinical failure, or death from prostate cancer. At a median 6.0 years, 109 of 608 men in the hypofractionated arm and 117 of 598 in the standard arm had an event, most of them PSA failures. Five-year biochemical and clinical failure-free survival was 85 percent in both arms, hazard ratio 0.96 (90 percent confidence interval 0.77 to 1.2), within the non-inferiority margin of 1.32.

Ten men in the short arm and 12 in the standard arm died of prostate cancer. No significant difference was detected between arms for grade 3 or worse late genitourinary or gastrointestinal toxicity, which is the contrast with RTOG 0415, where late grade 2 to 3 events did rise.