HYPO-RT-PC

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).

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

Phase

Phase 3

Sponsor

Umea University (Sweden)

Headline result

5-year failure-free survival 84% in both arms, non-inferior.

Reported

2019

Enrolled

1,200 randomised1,200 patients were enrolled and 1,180 formed the per-protocol population analysed; the trial is registered as ISRCTN45905321.

Replication

PACE-B found five-fraction stereotactic body radiotherapy non-inferior in 874 men with a longer median follow-up of 74 months.

Outcomes

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In plain words

What these results mean for people, not percentages

1,200 randomised

Failure-free survival at 5 yearsprimarysurvival endpoint

84 vs 84 out of 100 alive at 5 years with 42.7 Gy in 7 fractions compared with 78 Gy in 39 fractions; 0 more per 100.
No difference between the groups on this measure.

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Failure-free survival at 5 yearsprimarysurvival endpoint

84 vs 84 out of 100 alive at 5 years with Ultra-hypofractionation, 42.7 Gy in 7 fractions compared with Conventional fractionation, 78.0 Gy in 39 fractions; 0 more per 100.
No difference between the groups on this measure.
Put another way, the treated group had about 0 percent higher chance of the event at any given time (hazard ratio 1.002, likely range 0.758 to 1.325).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

RTOG grade 2 or worse urinary toxicity at 1 yearother endpoint

6 vs 2 out of 100 reached this endpoint at 1 year with Ultra-hypofractionation, 42.7 Gy in 7 fractions compared with Conventional fractionation, 78.0 Gy in 39 fractions; 4 more per 100.
On this measure the first group did worse, not better.

The p-value (0.0037) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.

Caveats

These results apply to the people the trial enrolled: Intermediate- and high-risk prostate cancer: 42.7 Gy in seven fractions over two and a half weeks versus 78 Gy in 39 fractions. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,200 randomised.

Failure-free survival at 5 yearsprimary

42.7 Gy in 7 fractions84 of 100

n = 598

78 Gy in 39 fractions84 of 100

n = 602

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Failure-free survival at 5 yearsprimary

HR 1.002 (0.758 to 1.325) · p = 0.99

Ultra-hypofractionation, 42.7 Gy in 7 fractions84 of 100

n = 589

Conventional fractionation, 78.0 Gy in 39 fractions84 of 100

n = 591

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Source

RTOG grade 2 or worse urinary toxicity at 1 year

· p = 0.0037

Ultra-hypofractionation, 42.7 Gy in 7 fractions6 of 100

n = 528

Conventional fractionation, 78.0 Gy in 39 fractions2 of 100

n = 529

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Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Failure-free survival at 5 yearsprimary	42.7 Gy in 7 fractions	598	84%	-	-	-
Failure-free survival at 5 yearsprimary	78 Gy in 39 fractions	602	84%	-	-	-
Failure-free survival at 5 yearsprimary	Ultra-hypofractionation, 42.7 Gy in 7 fractions	589	84%	1.002 (0.758 to 1.325)	0.99	link
Failure-free survival at 5 yearsprimary	Conventional fractionation, 78.0 Gy in 39 fractions	591	84%	1.002 (0.758 to 1.325)	0.99	link
RTOG grade 2 or worse urinary toxicity at 1 year	Ultra-hypofractionation, 42.7 Gy in 7 fractions	528	6%	-	0.0037	link
RTOG grade 2 or worse urinary toxicity at 1 year	Conventional fractionation, 78.0 Gy in 39 fractions	529	2%	-	0.0037	link

Replication

PACE-B found five-fraction stereotactic body radiotherapy non-inferior in 874 men with a longer median follow-up of 74 months.

Notes

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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).

Key papers

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rctThe Lancet 2019662 citations

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial

One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.

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