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.)

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

“…Guidelines are often based on expert opinion or weak evidence [4], and new trials are therefore required to tackle many major questions in urology. Studies such as the Prostate Cancer Intervention Versus Observation Trial [5] and the Prostate Testing for Cancer and Treatment trial (ProtecT) study [6,7] demonstrate that urological RCTs can be undertaken successfully. However, less than a third of trials achieve their original recruitment target [8].…”

The clinical communication and information challenges associated with the psychosexual aspects of prostate cancer treatment

“…Men diagnosed with PC face difficult choices between treatment options that can result in incontinence, infertility, feminisation, and chronic changes to sexual functioning, including erectile dysfunction, penile atrophy, and loss of libido (Chung and Brock, 2013;Donovan et al, 2016;PCUK, 2012).…”

Validation of the French-Canadian version of the Expanded Prostate Cancer Index Composite (EPIC) in a French-Canadian population

“…While these treatment modalities have demonstrated their efficacy in treating prostate cancer, they are associated with some toxicity and long-term side-effects. [2][3][4] Healthrelated quality of life (HRQOL) is an important parameter of treatment success and is now typically assessed in standard practices. 5 It is also an important aspect to take into account when helping patients choose the most appropriate treatment option for their condition.…”