Decision-making in localized prostate cancer treatments is informed by functional and QoL outcomes over six years, without any adverse outcomes on mental and physical QoL.
Radical localized prostate cancer treatments have positive oncological outcomes. Quality of life (QoL) and functional outcomes are assessed using patient-reported outcome measures (PROMs). This study aimed to analyze the QoL and functional PROMs in the Prostate Testing for Cancer and Treatment (ProtecT) trial and treatment decision-making.
The study, published in BJU International, comprised 2640 males aged 50-69 years who underwent prostate-specific antigen (PSA) testing at nine UK urology centers between 1999 and 2009. The diagnosis of clinically localized prostate cancer was confirmed on biopsy. Of the 2565 participants included in the final analysis, 1135 were randomized to active monitoring (AM), 750 were randomized to radical prostatectomy, and 603 were randomized to external-beam radiotherapy (EBRT) and concurrent androgen-deprivation therapy (ADT). The remaining 77 patients were not randomized and received low-dose-rate brachytherapy (BT). The investigators obtained validated PROMs at the time of diagnostic biopsy, at six months, and then annually from randomization of participants into treatment groups for six years.
Patients randomized to AM experienced associated functional deterioration. Nocturia and voiding symptoms gradually increased to 38% from 20% in 6 years without any changes in the urinary summary, use of urinary pads, functional outcomes, bother scores, urination frequency, and worsening of urinary QoL. The onset of erectile dysfunction and associated QoL outcomes increased to 53% and 22%, respectively, in 6 years.
There were no other significant findings in this treatment group. Study participants subjected to EBRT and BT reported changes in urinary, bowel, and sexual function. After the administration of EBRT and BT, 42% and 43% of men, respectively, reported nocturia immediately; however, it became less than or comparable to AM by 6 years. In the first year of treatment with BT, the patients reported higher irritative scores and urinary voiding symptoms. Neither BT nor EBRT affected functional outcomes, bother scores, urinary incontinence, urinary summary, or QoL. At 6 years, erectile dysfunction was reported by 74% of men following EBRT, while 51% of participants administered BT reported erectile dysfunction in the first year, which was comparable to men on AM (52%) by 6 years. The EBRT treatment group also reported some degree of fecal incontinence, loose stools, and bloody stools.
Men subjected to radical prostatectomy (RP) reported sexual dysfunction and urinary incontinence, with 36% of the patients reporting urinary leakage, which was reduced to 20% by six years. Increased daytime urination frequency and nocturia decreased from 41% to 33% and 27% to 22%, respectively, in six years following the treatment. Mental health, physical health, and bowel functions remained unaltered.
In summary, the decision-making in localized prostate cancer treatments can be informed by functional and QoL outcomes over six years.
Lane, J. A., Donovan, J. L., Young, G. J., Davis, M., Walsh, E. I., Avery, K. N. L., Blazeby, J. M., Mason, M. D., Martin, R. M., Peters, T. J., Turner, E. L., Wade, J., Bollina, P., Catto, J. W. F., Doherty, A., Gillatt, D., Gnanapragasam, V., Hughes, O., Kockelbergh, R., . . . Metcalfe, C.