# PROFIT (Prostate Fractionated Irradiation Trial)

Source: https://onco.cc/trials/profit-trial/  
OnCo record `profit-trial` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Confirmed that four weeks of radiotherapy works as well as eight for intermediate-risk prostate cancer, without more long-term side effects.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: PROFIT; Prostate Fractionated Irradiation Trial; OCOG-PROFIT
- Registry id: NCT00304759
- Phase: 3
- Setting: Intermediate-risk localised prostate cancer without androgen deprivation: 60 Gy in 20 fractions over 4 weeks against 78 Gy in 39 fractions over 8 weeks, with biochemical or clinical failure as the primary endpoint and a non-inferiority margin of 7.5 percent
- Sponsor: Ontario Clinical Oncology Group with the Canadian Cancer Trials Group
- Enrolled: 1206
- Result: Five-year biochemical and clinical failure-free survival 85 percent in both arms (hazard ratio 0.96, 90 percent confidence interval 0.77 to 1.2); no significant difference in grade 3 or worse late toxicity.
- Outcomes: Biochemical or clinical failure-free survival at 5 years: Hypofractionated, 60 Gy in 20 fractions 85% vs Conventional, 78 Gy in 39 fractions 85%, HR 0.96
- Replication: CHHiP found the same for 60 Gy in 20 fractions against 74 Gy in 37 fractions in 3,216 men, and RTOG 0415 for 70 Gy in 28 fractions in low-risk disease.

## Sources

- ClinicalTrials.gov NCT00304759: https://clinicaltrials.gov/study/NCT00304759
- PROFIT (Journal of Clinical Oncology 2017): https://doi.org/10.1200/JCO.2016.71.7397

## Connected records

- cancers: [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-risk/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Hypofractionated radiotherapy](https://onco.cc/technologies/hypofractionated-radiotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- companies: [Canadian Cancer Trials Group (CCTG)](https://onco.cc/companies/cctg/)
- terms: [Curative intent vs palliative intent](https://onco.cc/terms/curative-intent/), [How many radiotherapy visits: the prostate fractionation trials](https://onco.cc/terms/prostate-radiotherapy-fractionation/), [Hypofractionation (fewer, larger radiotherapy doses)](https://onco.cc/terms/hypofractionation/), [PSA kinetics: PSA doubling time and PSA density](https://onco.cc/terms/psa-kinetics/)
- trials: [CHHiP](https://onco.cc/trials/chhip/), [HYPO-RT-PC](https://onco.cc/trials/hypo-rt-pc/), [RTOG 0415](https://onco.cc/trials/rtog-0415/)

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