In patients with localized prostate cancer, stereotactic body radiotherapy (SBR) was associated with less urinary incontinence and better sexual function, but slightly worse bowel function, compared with prostatectomy radical, according to an open-label randomized phase 3 trial evaluating quality of life outcomes.
Led by Nicholas van Asfrom the Royal Marsden Hospital and the Institute of Cancer Research in London, the results of this trial have been published online in the journal European Urology.
Compared to prostatectomy, it appears that radiotherapy may offer better urinary and sexual outcomes, but a higher risk of intestinal toxicity in patients with localized prostate cancer. However, no comparison has previously been made in a randomized trial using more modern treatment options, such as stereotactic body radiotherapy (SBR).
Methodology
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Researchers conducted the multicenter trial PACE-A to compare and evaluate quality of life outcomes in 123 patients (median age: 65.5 years) with low-to-intermediate risk localized prostate cancer. They were randomized to CRT (n = 63) or radical prostatectomy (n = 60).
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Of the 123 patients, 97 (79%) had a Gleason score of 3 + 4 and 116 (94%) had intermediate risk according to the National Comprehensive Cancer Network. Median follow-up was 60.7 months.
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Co-primary endpoints were urinary incontinence data, measured by the number of absorbent urinary diapers needed per day, and bowel function, assessed using the Expanded Cancer Index Composite Short Form. the prostate (Expanded Prostate Cancer Index Composite Short Form, EPIC-26).
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Secondary endpoints included erectile function (measured using the International Index of Erectile Function 5 questionnaire), clinician-reported genitourinary and gastrointestinal toxicity, and the International Prostate Symptom Score (International Prostate Symptom Score). Other patient-reported outcomes included EPIC-26 domain scores for irritative/obstructive urinary symptoms, and general urinary, bowel, and sexual problems.
Main results
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After 2 years, only 6.5% (3 out of 46) of patients who finally underwent CSR used one or more urinary protection products per day, compared to 50% (16 out of 32) of patients who underwent CSR. of a prostatectomy (p ‘urinary incontinence EPIC-26 (median: 77.3 versus 100 ; p = 0,003).
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Prostatectomy patients also had significantly lower sexual function scores (median: 18 versus 62.5 with RTSC; p Grade 2 or higher erectile dysfunction events were significantly more common in patients who underwent prostatectomy (63% versus 18 %).
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However, at 2 years, intestinal domain scores in the prostatectomy group were significantly higher than in the RSC group (median: 100 versus 87.5), with an average difference of 8.9.
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Overall, physician-reported genitourinary and gastrointestinal toxicities were low in both treatment groups.
In practice
“The PACE-A study provides level 1 evidence of improvement in urinary incontinence and sexual function and worsening of bowel complaints in CRS compared with prostatectomy,” write the authors, adding that the trial “provides up-to-date toxicity estimates to optimize treatment decisions and maximize individual quality of life.” »
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