Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer

Abstract

Background: Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes.

Methods: We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle.

Results: The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life.

Conclusions: 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. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

Figure 1. Outcomes for Urinary Function and Effect on Quality of Life.

Shown are the effects of the treatments on urinary function (including urinary incontinence) and quality of life. The International Consultation on Incontinence Questionnaire (ICIQ) incontinence scores, shown in Panel A, range from 0 to 21. Panel B shows the percentage of men who used one or more absorbent pads per day for urinary incontinence, as assessed by the Expanded Prostate Cancer Index Composite (EPIC) instrument. In Panel C, the percentages shown are for men who reported a moderate-to-severe incontinence problem, as assessed by the ICIQ. The EPIC urinary scores, shown in Panel D, comprise several urinary symptoms, including incontinence; scores are formed by linear transformation of raw scores and range from 0 to 100. The International Continence Society Male Short-Form (ICSmaleSF) voiding scores, shown in Panel E, range from 0 to 20. Panel F shows the percentage of men reporting that urinary symptoms affected their quality of life somewhat to a lot, and Panel G, the percentage of men reporting nocturia at least two times per night — both as assessed by the ICSmaleSF. The P values show the strength of evidence for a difference in mean response over 6 years of follow-up across the three groups, with P values of 0.01 or lower indicating strong evidence of a difference. I bars represent 95% confidence intervals.

Figure 2. Outcomes for Sexual Function and Effect on Quality of Life.

Shown are the effects of the treatments on sexual function (including erectile dysfunction) and quality of life. Panel A shows the percentage of men reporting erections firm enough for intercourse. In Panel B, the percentages are for men who reported a moderate-to-severe problem with erectile dysfunction. The EPIC sexual function scores, shown in Panel C, range from 0 to 100. The EPIC sexual bother scores, shown in Panel D, range from 0 to 100. In Panel E, the percentages are for men who reported a moderate-to-severe effect on sexual quality of life. The P values show the strength of evidence for a difference in mean response over 6 years of follow-up across the three groups, with P values of 0.01 or lower indicating strong evidence of a difference. I bars represent 95% confidence intervals.

Figure 3. Outcomes for Bowel Function and Effect on Quality of Life.

Shown are the effects of the treatments on bowel function and quality of life. In Panel A, the EPIC bowel function scores range from 0 to 100. In Panel B, the EPIC bowel bother scores range from 0 to 100. In Panel C, the percentages are for men who reported having loose stools half the time or more. In Panel D, the percentages are for men who reported having fecal incontinence at least once per week. In Panel E, the percentages are for men who reported having bloody stools half the time or more. In Panel F, the percentages are for men who reported a moderate-to-severe negative effect on bowel habits. The P values show the strength of evidence for a difference in mean response over 6 years of follow-up across the three groups, with P values of 0.01 or lower indicating strong evidence of a difference. I bars represent 95% confidence intervals.

Figure 4. Outcomes for Health-Related Quality of Life.

Shown are the effects of the treatments on health-related quality of life. Medical Outcomes Study 12-Item Short-Form General Health Survey (SF-12) physical health scores (Panel A) and mental health scores (Panel B) range from 0 to 100. “Possible case” indicates the percentages of patients, who were assessed with the use of the Hospital Anxiety and Depression Scale (HADS), with scores suggesting clinically significant cases of anxiety (Panel C) and depression (Panel D). The P values show the strength of evidence for a difference in mean response over 6 years of follow-up across the three groups, with P values of 0.01 or lower indicating strong evidence of a difference. I bars represent 95% confidence intervals.