PACE-B
Prostate Advances in Comparative Evidence (PACE), PACE-B: intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer
Phase 3N = 874NCT01584258
- Population
- Men aged 18 years and older with WHO performance status 0 to 2 and low- or intermediate-risk prostate adenocarcinoma (Gleason 4+3 excluded)
- Design
- PACE is an open-label, multicohort, randomised phase 3 trial at 35 hospitals in the UK, Ireland and Canada. In PACE-B, 874 men with low- or intermediate-risk prostate adenocarcinoma (Gleason 4+3 excluded) were randomly allocated 1:1 between August 2012 and January 2018 to control radiotherapy (78 Gy in 39 fractions over 7.8 weeks or, after a protocol amendment on 24 March 2016, 62 Gy in 20 fractions over 4 weeks; 441 men) or SBRT (36.25 Gy in five fractions over 1 to 2 weeks; 433 men). Androgen deprivation was not permitted. Co-primary outcomes of this toxicity report: RTOG grade 2 or worse gastrointestinal and genitourinary toxicity at 24 months. Analysis by treatment received. Biochemical outcomes were awaited at the time of this report.
- Primary endpoint
- RTOG grade 2 or worse gastrointestinal toxicity, RTOG grade 2 or worse genitourinary toxicity
- Arms
- Control radiotherapy (control, n = 441): 78 Gy in 39 fractions over 7.8 weeks or 62 Gy in 20 fractions over 4 weeks
- SBRT (experimental, n = 433): Stereotactic body radiotherapy 36.25 Gy in five fractions over 1 to 2 weeks
- People
- Tree AC, PACE Trial Investigators
Δ 24-month RTOG grade 2 or worse genitourinary toxicity+1 pointsΔ 24-month RTOG grade 2 or worse gastrointestinal toxicity−1 points
Show the numbers
| Endpoint | Analysis | SBRT | Control radiotherapy | Effect |
|---|---|---|---|---|
| RTOG grade 2 or worse genitourinary toxicityTreated patients assessed at 24 months (analysis by treatment received; 381 control radiotherapy, 384 SBRT)RTOG grade 2 or worse genitourinary toxicity at 24 months (co-primary outcome of the 2-year toxicity report) | primaryTree 2022 | 3% at 2 y | 2% at 2 y | P=0.398 of 381 vs 13 of 384; absolute difference 1.3% (95% CI -1.3 to 4.0). Two-year toxicity report only; no oncological outcomes. |
| RTOG grade 2 or worse gastrointestinal toxicityTreated patients assessed at 24 months (analysis by treatment received; 382 control radiotherapy, 384 SBRT)RTOG grade 2 or worse gastrointestinal toxicity at 24 months (co-primary outcome of the 2-year toxicity report) | primaryTree 2022 | 2% at 2 y | 3% at 2 y | P=0.3211 of 382 vs 6 of 384; absolute difference -1.3% (95% CI -3.9 to 1.1). Two-year toxicity report only; no oncological outcomes. |
| Endpoint | Analysis | SBRT | Control radiotherapy | Effect |
|---|---|---|---|---|
| RTOG grade 2 or worse genitourinary toxicityTreated patients assessed at 24 months (analysis by treatment received; 381 control radiotherapy, 384 SBRT)RTOG grade 2 or worse genitourinary toxicity at 24 months (co-primary outcome of the 2-year toxicity report) | primaryTree 2022 | 3% at 2 y | 2% at 2 y | P=0.398 of 381 vs 13 of 384; absolute difference 1.3% (95% CI -1.3 to 4.0). Two-year toxicity report only; no oncological outcomes. |
| RTOG grade 2 or worse gastrointestinal toxicityTreated patients assessed at 24 months (analysis by treatment received; 382 control radiotherapy, 384 SBRT)RTOG grade 2 or worse gastrointestinal toxicity at 24 months (co-primary outcome of the 2-year toxicity report) | primaryTree 2022 | 2% at 2 y | 3% at 2 y | P=0.3211 of 382 vs 6 of 384; absolute difference -1.3% (95% CI -3.9 to 1.1). Two-year toxicity report only; no oncological outcomes. |
Appears in
Sources
Tree AC, Ostler P, van der Voet H, Chu W, Loblaw A, Ford D, et al. Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2022;23(10):1308-1320.