PACE-B showed that five stereotactic treatments control low- and intermediate-risk prostate cancer as well as four to eight weeks of conventional radiotherapy, with similar side effects at five years.
PACE-B randomised 874 men to stereotactic body radiotherapy (36.25 Gy in five fractions over one to two weeks) or conventional radiotherapy (78 Gy in 39 or 62 Gy in 20 fractions), without hormone therapy. Five-year freedom from biochemical or clinical failure was 95.8 percent with SBRT and 94.6 percent with conventional treatment, meeting non-inferiority; genitourinary toxicity of grade 2 or worse was somewhat higher after SBRT (van As and colleagues, New England Journal of Medicine 2024). Five-fraction treatment is now a standard option.
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.
874 randomised.
Confidence interval is 90 percent, as prespecified; critical hazard ratio for non-inferiority 1.45.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Freedom from biochemical or clinical failure at 5 yearsprimary | SBRT 36.25 Gy in 5 | 433 | 95.8% | - | - | - |
| Conventional radiotherapy | 441 | 94.6% | ||||
| Freedom from biochemical or clinical failure at 5 yearsprimary | Stereotactic body radiotherapy, 36.25 Gy in 5 fractions | 433 | 95.8% | 0.73 (0.48 to 1.12) | 0.004 for non-inferiority | link |
| Control radiotherapy, 78 Gy in 39 or 62 Gy in 20 fractions | 441 | 94.6% | ||||
| Late RTOG grade 2 or higher genitourinary toxicity at 5 years | Stereotactic body radiotherapy | 433 | 26.9% | - | <0.001 | link |
| Control radiotherapy | 441 | 18.3% | ||||
| Late RTOG grade 2 or higher gastrointestinal toxicity at 5 years | Stereotactic body radiotherapy | 433 | 10.7% | - | 0.94 | link |
| Control radiotherapy | 441 | 10.2% |
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.
A second publication from the PACE-B trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT01584258 with the most citations, so it is the natural first reading for anyone following the PACE-B trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Non-inferiority margin and equivalence trials, Non-inferiority trial, Hypofractionated radiotherapy and the tag radiation-wave2.
Shares Hypofractionated radiotherapy, The Institute of Cancer Research and the tag radiation-wave2.
Shares Hypofractionated radiotherapy, The Institute of Cancer Research and the tag radiation-wave2.
Shares SBRT / SABR (stereotactic radiotherapy) and the tag radiation-wave2.
Shares SBRT / SABR (stereotactic radiotherapy) and the tag radiation-wave2.
Shares HYPO-RT-PC, RTOG 0415, How many radiotherapy visits: the prostate fractionation trials, CHHiP.
Shares Choosing treatment for localised prostate cancer: what each option costs, ProtecT, Localised prostate cancer, very low and low risk, Localised prostate cancer, intermediate risk.
Shares Choosing treatment for localised prostate cancer: what each option costs, ProtecT, Localised prostate cancer, very low and low risk, Localised prostate cancer, intermediate risk.