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Even accounting for age-related symptoms and disease, treatment of prostate cancer came with higher rates of complications associated with worse quality of life and new health risks, a cohort study showed.

At 12 years, the risk of urinary or sexual complications was seven times greater after prostatectomy (HR 7.23, 95% CI 5.96-8.78) and nearly three times greater after radiotherapy (HR 2.76, 95% CI 2.26-3.37) compared with a control group of males without prostate cancer (both P<0.001), researchers led by Joseph Unger, PhD, of the Fred Hutchinson Cancer Center in Seattle, reported in .

Furthermore, participants treated with radiotherapy had a nearly threefold greater risk of bladder cancer than the untreated population (HR 2.78, 95% CI 1.92-4.02, P<0.001), including an increased risk of bladder cancer requiring cystectomy (HR 3.56, 95% CI 1.40-9.02, P=0.008). Radiation-specific outcome risk was particularly high, including a 131-fold increased risk of radiation cystitis and an 87-fold higher risk of radiation proctitis (both P<0.001).

In addition, 12-year risk of erectile dysfunction, urinary incontinence, and placement of penile prosthesis were more than twofold greater after radiotherapy compared with the untreated individuals in the control population.

"Complications after prostate cancer treatment are common and are associated with a myriad of harms," Unger and colleagues wrote. "Inadequate understanding of these risks may lead to patients regretting their treatment decisions. Accurate characterization of treatment risks is vital for informed decision-making, especially because complications can occur early after treatment whereas benefits may accrue years later."

They added that the magnitude of risk compared with "the relatively small benefit found by randomized clinical trials of prostate cancer screening and treatment" should be reflected in cancer screening and treatment guidelines, and also highlight the importance of patient counseling before screening, biopsy, or treatment.

"No national organization currently includes quantitative information on prostate cancer treatment-related risks and benefits," the authors concluded. "We recommend it be included to encourage truly informed decision-making."

In this study, the authors linked Medicare claims records with data from the (PCPT) and (SELECT).

Of the 51,961 total participants in those trials, 29,196 had records that were linked to Medicare with coverage of 12 months or more. Mean age at time-at-risk initiation was 68.7 years, and 8.4% were Black and 91.6% other racial groups.

Of the Medicare-linked cohort in the study, 3,946 participants were diagnosed with prostate cancer, of whom 655 and 1,056 were treated with prostatectomy and radiotherapy, respectively.

The median follow-up duration for the entire cohort was 10.2 years, totaling 312,882 person-years of follow-up. Of these, 6,855 person-years occurred after prostatectomy (median 10.5 years), and 8,949 person-years occurred after radiotherapy (median 8.5 years).

The 12-year risk of any complication was 6.57 times greater (95% CI 5.39-8.01, P<0.001) for prostatectomy compared to untreated participants. The difference in risk of any complications for prostatectomy was greatest early in the follow-up period, and decreased over time as untreated participants experienced aging-related events.

Risk of any complication at 12 years was three times greater (HR 3.04, 95% CI 2.51-3.67, P<0.001) for radiotherapy-treated participants compared with those untreated.

Unger and colleagues acknowledged the study had several limitations. For example, they noted that the PCPT and SELECT trials were randomized prevention trials, with inclusion and exclusion criteria that determined eligibility and could limit the generalizability of their incidence estimates.

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