LBA 10 - Long term outcomes of sexual function in the PACE-A trial: A multicentre randomised study of radical prostatectomy vs stereotactic body radiotherapy (SBRT) for early localised prostate cancer
Presenter(s)
B. Yasar1, J. Patel2, A. Tree3, P. Ostler4, H. Van Der Voet5, D. Ford6, S. Tolan7, P. Wells8, R. I. Mahmood9, M. Winkler10, A. K. Chan11, A. Thompson12, C. Ogden13, O. Naismith14, D. Price15, S. Brown3, G. Manning3, S. Burnett3, E. Hall3, and N. van As12; 1Barts Health NHS Foundation Trust, London, United Kingdom, 2The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, United Kingdom, 3The Institute of Cancer Research, London, United Kingdom, 4Mount Vernon Cancer Centre, Northwood, United Kingdom, 5The James Cook University Hospital, Middlesbrough, United Kingdom, 6University Hospital Birmingham, West Midlands, United Kingdom, 7The Clatterbridge Cancer Centre, Liverpool, United Kingdom, 8St. Bartholomew's Hospital, London, United Kingdom, 9Colchester Hospital University NHS Foundation Trust, Colchester, Essex, United Kingdom, 10Charing Cross Hospital, London, United Kingdom, 11Arden Cancer Centre, Coventry, United Kingdom, 12The Royal Marsden NHS Foundation Trust, London, United Kingdom, 13The Royal Marsden Hospital, London, United Kingdom, 14Radiotherapy Trials Quality Assurance Group, London, United Kingdom, 15Independent Patient and Public Representative, London, United Kingdom
Purpose/Objective(s):
Treatment selection for early localised prostate cancer (LPCa) is largely driven by functional outcomes. We aimed to compare long-term sexual function, a key and often distressing side effect, following prostatectomy versus stereotactic body radiotherapy (SBRT).Materials/Methods:
PACE (NCT01584258) is a phase III open-label multiple-cohort randomised control trial. In PACE-A, men with LPCa (cT1-T2, Gleason score =3+4, PSA =20 ng/mL) and suitable for prostatectomy were randomised (1:1) to SBRT or prostatectomy. SBRT dose was 36.25Gy/5 fractions in 1-2 weeks. Prostatectomy could be open, laparoscopic, or robot assisted. Androgen deprivation therapy was not permitted. Previously reported co-primary endpoints were 2-year bowel and urinary symptoms. Secondary sexual function outcomes, reported here through 5 years, included the EPIC-26 sexual domain score, the proportion of patients experiencing a minimally clinically important deterioration (MCID =11-point reduction), IIEF-5 score, and clinician-reported CTCAE grade =2 erectile dysfunction. Analyses were performed according to treatment received. A p-value <0.01 was considered statistically significant.Results:
Between August 2012 and February 2022, 123 participants were randomised (60 prostatectomy; 63 SBRT). Fifty patients received prostatectomy as allocated (1 SBRT, 3 chemoradiotherapy, 6 withdrew), while 60 received SBRT as allocated (2 prostatectomy, 1 withdrew). At 5 years, participant- and clinician-reported data were available for 30/50 (60%) and 43/50 (86%) of the prostatectomy group, and 38/60 (63%) and 57/60 (95%) of the SBRT group. At 5 years, sexual function was significantly worse following prostatectomy than SBRT. Over the 5-year period, median EPIC-26 sexual domain scores declined from 62 to 17 after prostatectomy and from 79 to 58 after SBRT; median change from baseline: -42 (IQR: -58 to -24) and -17 (IQR: -43 to 0) respectively (p = 0.02). A greater proportion of prostatectomy patients had reductions exceeding the MCID: (18/22 [82%] vs 19/35 [54%]; p=0.03). IIEF-5 scores were also lower following prostatectomy (median 5 vs 19; p<0.001). Rates of clinician-reported CTCAE grade =2 erectile dysfunction were similar between groups (13/37 [35%] vs 13/48 [27%]; p=0.48).Conclusion:
PACE-A provides the first randomised comparison of SBRT and prostatectomy for localised prostate cancer with long-term patient- and clinician-reported sexual outcomes. Prostatectomy was associated with substantially greater deterioration in sexual function and worse overall sexual outcomes than SBRT at 5 years, providing important information for shared treatment decision-making.