onc brain

About · curated by Nick Boehling, MD · @nb2276
Confirmatory

PACE-B

ForLow-/intermediate-risk localised prostate cancer, definitive RT

5-yr patient-reported urinary incontinence (EPIC-26 leak-free), SBRT vs CRT safety

64% vs 69% leak-free

diff +5.51% (95% CI -2.70 to +13.72), p=0.19

TL;DR5-yr PROMs: leak-free 64% (164/258) SBRT vs 69% (172/249) CRT, p=0.19; no domain differed significantly.

Why it mattersRadiation oncology

The transient 2-yr urinary leakage excess after SBRT converged by 5 yr, which is the number that settles the fractionation conversation: 36.25 Gy/5 fx carried no durable continence penalty against 78 Gy/39 fx or 62 Gy/20 fx. Note the irritative/obstructive domain was not collected, so the symptom cluster patients complain of most after SBRT is unmeasured here.

Monday clinic

In low-/intermediate-risk localised prostate cancer choosing between five-fraction SBRT and conventional or moderately hypofractionated RT, these 5-yr PROMs support fractionation choice on convenience rather than late continence, sexual, or bowel risk; they do not extend to high-risk disease, nodal treatment, or randomised comparison with prostatectomy.

11 details 4 trials watching

Phase 3 international randomised trial, 1:1 central allocation by ICR-CTSU with permuted blocks, stratified by centre and NCCN risk group. Treatment allocation was open-label. Of 874 randomised, 844 formed the analysis population (SBRT=414, CRT=430), median follow-up 85.7 and 85.6 mo.

Men with low-/intermediate-risk localised prostate cancer. Baseline characteristics balanced; baseline PROM data pooled across arms given equivalent pretreatment function.

SBRT 36.25 Gy in five fractions versus CRT 78 Gy in 39 fractions or 62 Gy in 20 fractions. Image-guidance method was not analysed as a variable, and rectal spacer use is not reported in this analysis.

Primary comparison: SBRT vs CRT at 5 yr for each PROM endpoint, using EPIC-26 urinary incontinence, sexual and bowel domains plus the Vaizey faecal incontinence score at baseline, 1, 2 and 5 yr. Binary outcomes by chi-squared with Wilson 95% CIs; continuous by Mann-Whitney.

All predefined between-group differences were nonsignificant. Sexual domain median score fell from 48.7 (IQR 22.2-77.8) to 26.3 (IQR 16.7-57) for SBRT and 54.2 (IQR 27.8-75.0) to 24.3 (IQR 16.7-52.8) for CRT, p=0.89.

Moderate or big urinary leakage problems reached 6% (15/250) SBRT and 4% (9/244) CRT; bowel problems 5% in both arms. Solid stool incontinence never/rarely in 94% (232/248) SBRT and 90% (217/241) CRT; liquid stool 92% in both.

PACE-B previously showed SBRT non-inferior to conventional and moderately hypofractionated RT for efficacy but with higher cumulative GU adverse events; these PROMs argue that excess did not persist to 5 yr. Against TrueNTH's robotic prostatectomy benchmark at 1 yr (42% leak- and pad-free, 6% of baseline-potent men retaining intercourse-adequate erections), the RT curves sit far better, and PACE-A reported pad use of 4.6% after SBRT versus 46.9% after prostatectomy.

men with low-/intermediate-risk localised prostate cancer treated with definitive prostate-only RT
Does not represent high-risk or node-positive disease, patients receiving elective nodal or pelvic RT, or post-prostatectomy salvage.

The EPIC-26 irritative/obstructive domain was not included, removing the symptom cluster most often attributed to SBRT, though the authors note no 5-yr difference was seen in prior reporting. There is no untreated control arm, so age-related decline is unseparated from treatment effect, and no analysis by image-guidance method.

The clinically useful claim is narrow and real: five fractions buys convenience without a late functional cost relative to 20 or 39 fractions. The cross-modality framing against surgery is the weaker half, comparing separate cohorts at different timepoints with a shared instrument rather than a randomised contrast.

CONSORT flow
Randomized 874
SBRT
allocated 414
5yr leak-free 64%
CRT
allocated 430
5yr leak-free 69%

Prespecified 5-yr PROM analysis of a phase 3 RCT; all between-group differences nonsignificant, supporting five-fraction SBRT already in guideline use. Attrition to ~60% limits precision.

📚 Sources · 📄 1 paper
📄 PAPER Cooper; Patel; Moore et al. · European urology (2026-07)
Patient-reported Outcomes After Prostate Stereotactic Body Radiotherapy at 5 yr: Results from the PACE-B Trial.
Abstract
Patient-reported outcome measures (PROMs) complement oncological endpoints by capturing what matters most to patients. The TrueNTH surgical collaboration presented 1-yr PROMs following robotic prostatectomy using accessible visual formats. We present 5-yr PROMs from the phase 3, international PACE-B trial, which randomised men with localised prostate cancer to stereotactic body radiotherapy (SBRT) or conventionally fractionated radiotherapy (CRT). PROMs are reported from baseline to 5&#xa0;yr and presented using waffle charts to enable visual alignment with surgical outcomes. At 5&#xa0;yr, urinary incontinence outcomes were favourable and comparable between SBRT and CRT. Leak-free rates were 64% (164/258) for SBRT and 69% (172/249) for CRT, pad-free rates were 91% (233/257) for SBRT and 90% (225/250) for CRT, and moderate or big urinary leakage problems were reported by only 6% (15/250) for SBRT and 4% (9/244) for CRT. Intercourse-adequate erections declined in both groups from baseline to 5&#xa0;yr: from 35% (133/374) to 17% (43/250) for SBRT, and from 40% (157/391) to 20% (47/240) for CRT. Moderate or big sexual problems increased in both groups, from 24% (87/367) to 31% (74/242) for SBRT and from 22% (85/382) to 32% (77/238) for CRT. Bowel effects were low and comparable between groups, with moderate or big bowel problems reported by 2% (7/397) at baseline and 5% (12/265) for SBRT at 5&#xa0;yr, and 2% (9/415) at baseline and 5% (13/253) for CRT at 5&#xa0;yr. Stool incontinence as a moderate or big problem rose from <1% (1/374) to 2% (4/240) in the SBRT group and from <1% (1/395) to 3% (7/238) in the CRT group.

The longer read

The question PACE-B's PROM report actually answers is narrower than its cross-modality framing suggests, and it is the more useful of the two. Ultrahypofractionation to 36.25 Gy in five fractions has been adopted on efficacy non-inferiority, but the earlier physician-reported signal of higher cumulative GU adverse events left an open worry that the convenience was being paid for in late urinary function. At 5 yr the patient-reported data do not support that worry. Leak-free rates were 64% versus 69%, pad-free 91% versus 90%, and the combined leak- and pad-free endpoint identical at 88%; the difference in proportions for that combined endpoint was +0.08% with a confidence interval spanning roughly six points either way. The transient 2-yr excess in moderate or big leakage problems after SBRT, which mirrored the clinician-reported GU events, had converged by 5 yr. That trajectory matters more than any single timepoint: it recasts the known GU signal as an early and intermediate phenomenon rather than a durable deficit, which is precisely the distinction a patient weighing five visits against twenty or thirty-nine needs.

How much should the nonsignificance move confidence? Less than the headline implies, and in a specific direction. EPIC-26 completion fell to 62% and 58% by 5 yr, so each proportion rests on roughly 250 respondents out of 433 and 441 allocated. Responder attrition in functional outcome studies is not plausibly random, and the leak-free comparison carries a five-point nominal gap favouring CRT with an interval reaching +13.72%. This analysis is powered to exclude a large difference, not a clinically meaningful modest one, and "no significant difference" here should be read as compatible with a small disadvantage in either direction. The open-label allocation compounds this for subjective self-report, though the direction of any expectation bias in a trial where the shorter schedule is the novel arm is not obvious.

A second gap constrains the read more sharply than the statistics do. The EPIC-26 irritative and obstructive domain was not collected. Urgency, frequency and flow are the symptoms that dominate the post-SBRT complaint profile, and their omission means the domain where the physician-reported excess most plausibly lived is the one domain unmeasured in this report. The authors note that no difference was seen at 5 yr in the prior PACE-B analysis, which is reassuring but is not the same as having those data alongside the continence and bowel results presented here. Nor is image-guidance method analysed, so the result should be read as belonging to the standard of delivery achieved across the trial's centres rather than to any particular platform or margin.

The cross-modality alignment with TrueNTH is the paper's stated novelty and the part that should be held loosest. The instrument and the visual presentation match, but a 1-yr surgical cohort compared with a 5-yr radiotherapy cohort from a different study is a benchmark, not a comparison; the gap it displays in continence and potency runs in the direction that PACE-A's randomised pad-use figures already showed, which is why the framing is credible even where the design is not. Nothing here speaks to high-risk disease, nodal coverage, or the patients for whom the surgery-versus-radiotherapy decision is genuinely contested. For the low- and intermediate-risk man choosing a fractionation schedule, though, the late functional argument for the longer course has now largely gone.