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Showed that men with low-risk prostate cancer can have five and a half weeks of radiotherapy instead of eight without losing control of the cancer, at the price of slightly more bowel and bladder trouble later.
RTOG 0415 randomised 1,115 men with low-risk prostate cancer 1:1 to conventional radiotherapy (73.8 Gy in 41 fractions over 8.2 weeks) or hypofractionated radiotherapy (70 Gy in 28 fractions over 5.6 weeks). The trial was designed to establish that hypofractionation did not reduce 5-year disease-free survival by more than 7.65 percent, a hazard ratio below 1.52.
Of 1,092 protocol-eligible men with follow-up, 542 received conventional and 550 hypofractionated treatment. At a median 5.8 years, estimated 5-year disease-free survival was 85.3 percent (95 percent confidence interval 81.9 to 88.1) with conventional treatment and 86.3 percent (83.1 to 89.0) with hypofractionation, hazard ratio 0.85 (0.64 to 1.14), meeting non-inferiority (p<0.001).
The cost was measurable: late grade 2 and 3 gastrointestinal and genitourinary adverse events were increased with hypofractionation, hazard ratios 1.31 to 1.59. That is the trade-off hypofractionation has consistently shown, and it is why a man with poor urinary function at baseline is often steered towards a longer course.
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.
1,115 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 5 yearsprimary | Hypofractionated, 70 Gy in 28 fractions | 550 | 86.3% | 0.85 (0.64 to 1.14) | <0.001 for non-inferiority | link |
| Conventional, 73.8 Gy in 41 fractions | 542 | 85.3% |
Shares CHHiP, Curative intent vs palliative intent, NRG Oncology, Localised prostate cancer, very low and low risk.
Shares How many radiotherapy visits: the prostate fractionation trials, CHHiP, PACE-B, IMRT / IGRT (modern external beam).
Shares CHHiP, PACE-B, Localised prostate cancer, very low and low risk, IMRT / IGRT (modern external beam).
Shares Curative intent vs palliative intent, NRG Oncology, IMRT / IGRT (modern external beam), Prostate cancer.
Shares Hypofractionation (fewer, larger radiotherapy doses), Hypofractionated radiotherapy, IMRT / IGRT (modern external beam).
Shares Hypofractionation (fewer, larger radiotherapy doses), Hypofractionated radiotherapy, IMRT / IGRT (modern external beam).
Shares PROFIT (Prostate Fractionated Irradiation Trial), PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk, Prostate cancer.
Shares PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk, Prostate cancer.