Patient-Reported Outcomes After Active Monitoring, Surgery, or Radiotherapy in PSA-Detected Localized Prostate Cancer
Patient-reported outcomes differed among men with localized prostate cancer detected by prostate-specific antigen (PSA) testing who were randomized to receive active monitoring, surgery, or radiotherapy in the UK ProtecT trial, according to a report by Donovan et al in The New England Journal of Medicine. The effects on sexual function and urinary incontinence were worse with surgery, and the effects on bowel function were worse with radiotherapy.
Study Details
In the trial, 1,643 men aged 50 to 69 years were randomized between 1999 and 2009 to receive active monitoring (n = 545), surgery (n = 553), or radiotherapy (n = 545). No significant differences in 10-year prostate cancer–specific or overall mortality were observed among treatment groups; metastases and disease progression were more common with active monitoring. Radical treatment was ultimately received by 54.8% of the active monitoring group.
Patient-reported outcomes in urinary, bowel, and sexual function and associated effects on quality of life, as well as in anxiety and depression and general health–related quality of life were assessed before diagnosis, at 6 and 12 months, and then annually for up to 6 years. Cancer-related quality of life was assessed at 5 years.
Patient-Reported Outcomes
Findings included the following:
- Prostatectomy was associated with the worst effect on sexual function and urinary continence; despite evidence of some recovery over time, these outcomes remained worse vs radiotherapy and monitoring over 6 years.
- A negative effect of radiotherapy on sexual function reached a peak at 6 months, and then it recovered somewhat and stabilized. Radiotherapy had no marked effect on urinary continence. Urinary voiding and nocturia problems were worst in the radiotherapy group at 6 months but were similar to those in the other groups after 12 months.
- Sexual and urinary function declined gradually in the active monitoring group.
- Bowel function was worst with radiotherapy at 6 months; it then recovered somewhat except for a persistent increased frequency of bloody stools. Bowel function was generally unchanged in the prostatectomy and monitoring groups.
- Effects on quality of life of reported urinary, sexual, and bowel function reflected the reported changes in function in all groups.
- No significant differences among groups were observed for anxiety, depression, general health–related quality of life, or cancer-related quality of life.
The investigators concluded: “In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups.”
The study was funded by the UK National Institute for Health Research.
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