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Bending the Curve Trial by Trial
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PROFIT

A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer (PROFIT)

NCT00304759

Population
Men with intermediate-risk localized prostate cancer (T1 to 2a, Gleason score 6 or lower and PSA 10.1 to 20 ng/mL; T2b to 2c, Gleason 6 or lower and PSA 20 ng/mL or lower; or T1 to 2, Gleason 7 and PSA 20 ng/mL or lower)
Design
Multicenter randomized non-inferiority trial in intermediate-risk prostate cancer: conventional radiotherapy of 78 Gy in 39 fractions over 8 weeks (598 patients) or hypofractionated radiotherapy of 60 Gy in 20 fractions over 4 weeks (608 patients). Androgen deprivation was not permitted. Primary outcome: biochemical-clinical failure (PSA failure by nadir + 2, hormonal intervention, clinical local or distant failure, or death from prostate cancer); non-inferiority margin 7.5% (hazard ratio below 1.32).
Primary endpoint
BCF-free survival
Arms
  • 78 Gy in 39 fractions (control, n = 598): 78 Gy in 39 fractions over 8 weeks
  • 60 Gy in 20 fractions (experimental, n = 608): 60 Gy in 20 fractions over 4 weeks
People
Catton CN, senior author Levine MN
BCF-free survivalHR 0.96Δ 60-month BCF-free survival0 points
Show the numbers
Results reported for PROFIT
EndpointAnalysis60 Gy in 20 fractions78 Gy in 39 fractionsEffect
BCF-free survivalRandomized intermediate-risk patients (analysis population not stated in the abstract)5-year biochemical-clinical failure disease-free survival (primary outcome: biochemical-clinical failure)primarymedian follow-up 6 yearsCatton 201785% at 5 y85% at 5 yHR 0.96Hazard ratio 0.96 has a 90% CI of 0.77 to 1.2. 109 of 608 patients (hypofractionated) vs 117 of 598 (standard) had biochemical-clinical failure, mostly PSA failures. Ten deaths from prostate cancer in the short arm and 12 in the standard arm. No significant differences in grade 3 or higher late genitourinary and gastrointestinal toxicity.
Results reported for PROFIT
EndpointAnalysis60 Gy in 20 fractions78 Gy in 39 fractionsEffect
BCF-free survivalRandomized intermediate-risk patients (analysis population not stated in the abstract)5-year biochemical-clinical failure disease-free survival (primary outcome: biochemical-clinical failure)primarymedian follow-up 6 yearsCatton 201785% at 5 y85% at 5 yHR 0.96Hazard ratio 0.96 has a 90% CI of 0.77 to 1.2. 109 of 608 patients (hypofractionated) vs 117 of 598 (standard) had biochemical-clinical failure, mostly PSA failures. Ten deaths from prostate cancer in the short arm and 12 in the standard arm. No significant differences in grade 3 or higher late genitourinary and gastrointestinal toxicity.
Primary publication: Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, et al. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017;35(17):1884-1890. PubMedDOI

Appears in

Sources

  1. Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, et al. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017;35(17):1884-1890.

    PubMedDOI