A Phase III randomized controlled trial of Stereotactic Body Radiotherapy in localized prostate cancer
Abstract
Background PACE-B aims to demonstrate non-inferiority of Stereotactic Body Radiotherapy (SBRT) compared to conventionally or moderately hypo-fractionated regimens for biochemical and/or clinical failure for localised prostate cancer. Methods PACE-B is an international phase III open-label randomised controlled trial. Men with stage T1-T2 prostate cancer, Gleason ≤3+4, PSA ≤20 ng/mL were randomized (1:1) to SBRT (36.25 gray (Gy) in 5 fractions (f) over 1-2 weeks) or control radiotherapy (CRT) (78Gy/39f over 7.5 weeks, or 62Gy/20f over 4 weeks). Androgen deprivation therapy was not permitted. The primary endpoint was freedom from biochemical/clinical failure with a critical hazard ratio for non-inferiority of 1.45. Analysis was by intention to treat. Results 874 patients were randomised from 38 centers (CRT=441, SBRT=433) between August 2012 and January 2018. Median age was 69.8 years, median PSA 8.0 ng/mL, NCCN risk group was 9.3% low, 90.7% intermediate. After 74.0 months median follow-up, 5-year biochemical/clinical failure free-rate (95% CI) was CRT: 94.6% (91.9%, 96.4%) vs SBRT: 95.8% (93.3%, 97.4%). SBRT was non-inferior to CRT with unadjusted hazard ratio 0.73 (90% CI: 0.48, 1.12; p-value for non-inferiority 0.004). To 5 years, cumulative rate of late RTOG grade 2 or worse genitourinary toxicity was CRT: 18.3% (95%CI 14.8, 22.5%) vs. SBRT: 26.9% (95%CI 22.8, 31.5%) (p<0.001) and for gastrointestinal toxicity was CRT: 10.2% (95%CI 7.7, 13.5%) vs. SBRT: 10.7% (95%CI 8.1,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 874 participants or records.
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