Radical Prostatectomy Versus Stereotactic Radiotherapy for Clinically Localised Prostate Cancer: Results of the PACE-A Randomised Trial
Nicholas van As, Binnaz Yasar, Clare Griffin, Jaymini Patel, Alison Tree, Peter Ostler, H. van der Voet, Daniel Ford, Shaun Tolan, Paula Wells, Rana Mahmood, Mathias Winkler, Andrew K. Chan, Alan Thompson, Chris Ogden, Olivia Naismith, Julia Pugh, Georgina Manning, Stephanie Brown, Stephanie Burnett, Emma Hall
Abstract
Stereotactic body radiotherapy (SBRT) without androgen deprivation therapy (ADT) has lower rates of incontinence and sexual dysfunction, with a small trade-off in bowel bother, compared with prostatectomy. At 2 yr, 50% of men who underwent prostatectomy reported using urinary pads, compared with 6.5% who underwent SBRT, whilst only a modest reduction in the Expanded Prostate Index Composite (EPIC) bowel domain score was seen for SBRT compared with that for prostatectomy. Prostatectomy participants reported worse sexual function at 2 yr. Randomised data on patient-reported outcomes (PROs) for stereotactic body radiotherapy (SBRT) and prostatectomy in localised prostate cancer are lacking. PACE-A compared patient-reported health-related quality of life after SBRT with that after prostatectomy. PACE is a phase 3 open-label, randomised controlled trial. PACE-A randomised men with low- to intermediate-risk localised prostate cancer to SBRT or prostatectomy (1:1). Androgen deprivation therapy (ADT) was not permitted. The coprimary outcomes were the Expanded Prostate Index Composite (EPIC-26) number of absorbent urinary pads required daily and bowel domain score at 2 yr. The secondary endpoints were clinician-reported toxicity, sexual functioning, and other PROs. In total, 123 men were randomised (60 undergoing prostatectomy and 63 SBRT) from August 2012 to February 2022. The median follow-up time was 60.7 mo. The median age was 65.5 yr and the median prostate-specific antigen (PSA) value 7.9 ng/ml; 92% had National Comprehensive Cancer Network (NCCN) intermediate-risk disease. Fifty participants received prostatectomy and 60 received SBRT. At 2 yr, 16/32 (50%) prostatectomy and three of 46 (6.5%) SBRT participants used one or more urinary pads daily ( p < 0.001; 15 and two, respectively, used one pad daily); the estimated difference was 43% (95% confidence interval [CI]: 25%, 62%). At 2 yr, bowel scores were better for prostatectomy (median [interquartile range] 100 [100–100]) than for SBRT (87.5 [79.2–100]; p < 0.001), with an estimated mean difference of 8.9 between these (95% CI: 4.2, 13.7); sexual scores were worse for prostatectomy (18 [13.8–40.3]) than for SBRT (62.5 [32.0–87.5]). The limitations were slow recruitment and incomplete 2-yr PRO response rates. SBRT was associated with less patient-reported urinary incontinence and sexual dysfunction, and slightly more bowel bother than prostatectomy. These randomised data should inform treatment decision-making for patients with localised, intermediate-risk prostate cancer.