PACE-B
ForLow-/intermediate-risk localised prostate cancer, definitive RT
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.
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.
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.
The 2-yr urinary leakage excess after 36.25 Gy/5 fx converged by 5 yr, removing the late-toxicity argument for holding a low-/intermediate-risk patient on 78 Gy/39 fx or 62 Gy/20 fx. Caveat for consent: the EPIC-26 irritative/obstructive domain was not collected, so the urgency and flow symptoms patients ask about are unmeasured here.
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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.
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
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.
- Irritative/obstructive symptom trajectory at 5 yr after prostate SBRT active Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer Phase 3n=692 · primary completion 2027-12 · phase 3 SBRT vs IMRT with QoL questionnaire endpointrecruiting Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE) Phase 3n=320 · primary completion 2030-02 · adaptive vs image-guided SBRT, urinary outcomes
- Whether rectal spacer or image-guidance method alters 5-yr PROMs n=179 · primary completion 2027-04 · phase 3 CT- vs MRI-guided SBRT, questionnaire PROMsn=500 · primary completion 2027-12 · SpaceOAR Vue for late GI toxicity in SBRT pts, n=500
- 5-yr PROMs for the TrueNTH prostatectomy cohort
📚 Sources · 📄 1 paper
Abstract
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.