RCT: Stereotactic Body Radiotherapy Reduced Incontinence and Sexual Dysfunction vs. Prostatectomy in Localized Prostate Cancer
18 Sep, 2024 | 10:51h | UTCBackground: Men with localized prostate cancer have several treatment options, including prostatectomy and radiotherapy. Patient-reported outcomes (PROs) are crucial in guiding treatment decisions due to potential impacts on quality of life. However, randomized data comparing stereotactic body radiotherapy (SBRT) with prostatectomy are lacking.
Objective: To compare patient-reported urinary, bowel, and sexual outcomes at 2 years following SBRT versus prostatectomy in men with low- to intermediate-risk localized prostate cancer.
Methods: In the phase 3 PACE-A randomized controlled trial conducted in the UK from 2012 to 2022, 123 men with National Comprehensive Cancer Network (NCCN) low- to intermediate-risk localized prostate cancer were randomized 1:1 to receive either SBRT (36.25 Gy in five fractions) or prostatectomy. Androgen deprivation therapy was not permitted. The co-primary outcomes were the number of absorbent urinary pads used daily and the Expanded Prostate Index Composite (EPIC-26) bowel domain score at 2 years. Secondary outcomes included clinician-reported toxicity and sexual function.
Results: Among 110 men who received treatment (median age 65.5 years; median PSA 7.9 ng/ml; 92% intermediate-risk), 50 underwent prostatectomy and 60 received SBRT. At 2 years, 50% of prostatectomy patients reported using one or more urinary pads daily compared to 6.5% of SBRT patients (p < 0.001; difference 43%, 95% CI 25%–62%). Bowel domain scores were better for prostatectomy (median 100) than for SBRT (median 87.5; p < 0.001; mean difference 8.9, 95% CI 4.2–13.7). Sexual function scores were worse for prostatectomy (median 18) compared to SBRT (median 62.5; p < 0.001). Clinician-reported genitourinary and gastrointestinal toxicities were low in both groups.
Conclusions: SBRT was associated with significantly less urinary incontinence and sexual dysfunction but slightly worse bowel function compared to prostatectomy at 2 years in men with localized prostate cancer.
Implications for Practice: These findings provide preliminary evidence to inform treatment decisions for men with low- to intermediate-risk localized prostate cancer. SBRT may offer advantages in reducing urinary incontinence and sexual dysfunction, which are significant considerations for patients. Clinicians should also discuss the potential for increased bowel symptoms with SBRT.
Study Strengths and Limitations: Strengths include the randomized design, use of contemporary treatment modalities, and comprehensive assessment of PROs. Limitations involve the small sample size due to slow recruitment, differential dropout rates, and incomplete PRO responses at the 2-year mark.
Future Research: Larger-scale randomized trials are needed to confirm these findings, assess long-term outcomes beyond 2 years, and evaluate the impact on disease control and quality of life.