# HYPO-RT-PC

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

## TL;DR

The Scandinavian HYPO-RT-PC trial showed that seven large radiotherapy doses control intermediate- to high-risk prostate cancer as well as 39 conventional ones, with similar late side effects.

## Summary

HYPO-RT-PC randomised 1,200 men with intermediate- or high-risk prostate cancer, without hormone therapy, to ultra-hypofractionated radiotherapy (42.7 Gy in seven fractions, three per week) or conventional fractionation (78 Gy in 39). Five-year failure-free survival was 84 percent in both arms, meeting non-inferiority; acute urinary toxicity was higher with the short schedule but late toxicity was similar (Widmark and colleagues, Lancet 2019).

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-16
- Tags: radiation-wave2
- Phase: 3
- Setting: Intermediate- and high-risk prostate cancer: 42.7 Gy in seven fractions over two and a half weeks versus 78 Gy in 39 fractions
- Sponsor: Umea University (Sweden)
- Enrolled: 1200
- Result: 5-year failure-free survival 84% in both arms, non-inferior.
- Outcomes: Failure-free survival at 5 years: 42.7 Gy in 7 fractions 84% vs 78 Gy in 39 fractions 84%; Failure-free survival at 5 years: Ultra-hypofractionation, 42.7 Gy in 7 fractions 84% vs Conventional fractionation, 78.0 Gy in 39 fractions 84%, HR 1.002; RTOG grade 2 or worse urinary toxicity at 1 year: Ultra-hypofractionation, 42.7 Gy in 7 fractions 6% vs Conventional fractionation, 78.0 Gy in 39 fractions 2%
- Replication: PACE-B found five-fraction stereotactic body radiotherapy non-inferior in 874 men with a longer median follow-up of 74 months.

## Notes

- HYPO-RT-PC recruited men up to 75 years old with intermediate-to-high-risk prostate cancer at 12 centres in Sweden and Denmark between 1 July 2005 and 4 November 2015; 1,054 (89 percent) were intermediate risk and 126 (11 percent) high risk. No androgen deprivation therapy was allowed, which makes it a clean test of fractionation. Median follow-up was 5.0 years. Acute RTOG grade 2 or worse urinary toxicity at the end of radiotherapy was 28 percent with ultra-hypofractionation against 23 percent (p=0.057), and there were no significant differences in grade 2 or worse late urinary or bowel toxicity at 5 years (Lancet 2019).
- The patient-reported quality-of-life analysis to 6 years found that seven of ten bowel symptoms deteriorated significantly more at the end of radiotherapy with ultra-hypofractionation (stool frequency, rush to toilet, flatulence, bowel cramp, mucus, blood in stool and limitation in daily activity, all p at most 0.0014), with no clinically relevant differences thereafter. At 6 years there was no difference in overall urinary bother (28 against 33 percent), bowel bother (28 against 33 percent), sexual bother (50 against 60 percent) or global health (37 against 42 percent) (Lancet Oncology 2021).

## Sources

- ISRCTN45905321: https://www.isrctn.com/ISRCTN45905321
- Lancet 2019: https://doi.org/10.1016/S0140-6736(19)31131-6
- HYPO-RT-PC 5-year outcomes (Lancet 2019): https://doi.org/10.1016/S0140-6736(19)31131-6
- HYPO-RT-PC patient-reported quality of life (Lancet Oncology 2021): https://doi.org/10.1016/S1470-2045(20)30581-7
- ISRCTN registry ISRCTN45905321: https://www.isrctn.com/ISRCTN45905321

## Connected records

- cancers: [Localised prostate cancer, high and very high risk](https://onco.cc/cancers/prostate-high-risk/), [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/), [SBRT / SABR (stereotactic radiotherapy)](https://onco.cc/technologies/sbrt/)
- terms: [How many radiotherapy visits: the prostate fractionation trials](https://onco.cc/terms/prostate-radiotherapy-fractionation/)
- trials: [CHHiP](https://onco.cc/trials/chhip/), [PACE-B](https://onco.cc/trials/pace-b/), [PROFIT (Prostate Fractionated Irradiation Trial)](https://onco.cc/trials/profit-trial/), [RTOG 0415](https://onco.cc/trials/rtog-0415/)
- key papers: [Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial](https://onco.cc/key-papers/paper-widmark-lancet/)

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