A large cohort study investigating the long-term treatment-related adverse effects and complications from prostate cancer treatment compared to an untreated control group has found that treatment was associated with higher rates of 10 potential complications in the 12 years after treatment. Given the uncertain benefit of prostate cancer treatment for most patients, concluded the study authors, these findings highlight the importance of patient counseling before screening and treatment. The study by Unger et al is published in JAMA Oncology.
Study Methodology
The researchers linked data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin-E Cancer Prevention Trial with Medicare claims records for their analysis. The study included 29,196 participants, with a mean age at time-at-risk initiation of 68.7 years. Of these participants, 3,946 had prostate cancer, among whom 655 were treated with prostatectomy and 1,056 with radiotherapy.
Participants who had been diagnosed with prostate cancer but had not received treatment, along with those who had not been diagnosed with prostate cancer, served as an untreated control group. The researchers used multivariable Cox regression, with a time-varying covariate for the occurrence of prostate cancer treatment, adjusted for age, race, and year of time-at-risk initiation, and stratified by study and intervention arm. The data analyses were performed from September 21, 2022, to March 18, 2024.
Results
The researchers found the 12-year hazard risk of urinary or sexual complications was 7.23 times greater for those with prostatectomy (95% confidence interval [CI] = 5.96–8.78; P <.001) and 2.76 times greater for radiotherapy (95% CI = 2.26–3.37; P <.001) compared to the untreated participants. In addition, among participants treated with radiotherapy, there was a nearly threefold greater hazard risk of bladder cancer than in the untreated group (hazard ratio [HR] = 2.78; 95% CI = 1.92–4.02; P <.001), as well as an approximately 100-fold increased hazard risk of radiation-specific outcomes, including radiation cystitis (HR = 87.91; 95% CI = 48.12–160.61; P <.001).
The incidence per 1,000 person-years of any one of the 10 treatment-related complications was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
“This cohort study found that, even after accounting for age-related symptoms and disease, prostate cancer treatment was associated with higher rates of complications in the 12 years after treatment. Given the uncertain benefit of prostate cancer treatment for most patients, these findings highlight the importance of patient counseling before prostate cancer screening and treatment, and provide a rationale for pursuing opportunities for cancer prevention,” concluded the study authors.
Joseph M. Unger, PhD, MS, a biostatistician and health services researcher at the SWOG Statistics and Data Management Center, and Associate Professor in the Cancer Prevention Program at Fred Hutchinson Cancer Center, is the corresponding author of this study.
Disclosure: Funding for this study was provided by the National Institutes of Health, the National Cancer Institute, and The Hope Foundation for Cancer Research. For full disclosures of all study authors, visit JAMA Oncology.
