A large cohort study investigated the long-term treatment-related adverse effects and complications from prostate cancer treatment compared with an untreated control group. The investigators 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 was 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 for comparison.
Joseph M. Unger, PhD, MS
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 2022 to March 2024.
Key Results
The researchers found the 12-year hazard risk of urinary or sexual complications was 7.23 times greater with prostatectomy (95% confidence interval [CI] = 5.96–8.78; P < .001) and 2.76 times greater with radiotherapy (95% CI = 2.26–3.37; P < .001) compared with the untreated participants. In addition, among participants treated with radiotherapy, there was a nearly threefold greater hazard risk for bladder cancer than in the untreated group (hazard ratio = 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 (hazard ratio = 87.91; 95% CI = 48.12–160.61; P < .001). The incidence per 1,000 person-years of any of the 10 treatment-related complications was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
KEY POINTS
- Patients treated with prostatectomy had a 7.23 times greater risk for urinary or sexual complications, and patients treated with radiotherapy had a 2.76 times greater risk compared with untreated patients.
- After 12 years, patients who had received radiotherapy were nearly three times as likely as untreated patients to be diagnosed with bladder cancer.
- Patient counseling about the risk/benefit of screening and treatment is important for informed decision-making.
“We found that, after accounting for baseline population rates, most patients with prostate cancer undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of prostate cancer screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of prostate-specific antigen screening, biopsy, or prostate cancer treatment,” 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 the study in JAMA Oncology.
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 the study authors, visit jamanetwork.com.
