ImportanceDue to the often indolent nature of prostate cancer (PCA), treatment decisions must weigh the risks and benefits of cancer control with those of treatment-associated morbidities.ObjectiveTo characterize long-term treatment-related adverse effects and complications in patients treated for PCA compared to a general population of older males.Design, Setting, and ParticipantsThis cohort study used a novel approach linking data from 2 large PCA prevention clinical trials (the Prostate Cancer Prevention Trial and the Selenium and Vitamin-E Cancer Prevention Trial) with Medicare claims records. This analysis included patients with PCA who had been treated with prostatectomy or radiotherapy compared with an untreated control group. Multivariable Cox regression was used, with a time-varying covariate for the occurrence of PCA treatment, adjusted for age, race, and year of time-at-risk initiation, and stratified by study and intervention arm. Data analyses were performed from September 21, 2022, to March 18, 2024.ExposureProstatectomy and radiotherapy occurring after a PCA diagnosis, identified from trial data or Medicare claims records.Main Outcomes and MeasuresTen potential PCA treatment-related complications identified from Medicare claims data.ResultsThe study sample comprised 29 196 participants (mean [SD] age at time-at-risk initiation, 68.7 [4.8] years). Of these, 3946 participants had PCA, among whom 655 were treated with prostatectomy and 1056 with radiotherapy. The 12-year hazard risk of urinary or sexual complications was 7.23 times greater for those with prostatectomy (95% CI, 5.96-8.78; P < .001) and 2.76 times greater for radiotherapy (95% CI, 2.26-3.37; P < .001) compared to untreated participants. Moreover, among participants treated with radiotherapy, there was a nearly 3-fold greater hazard risk of bladder cancer than in the untreated (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, 131.47; 95% CI, 52.48-329.35; P < .001) and radiation proctitis (HR, 87.91; 95% CI, 48.12-160.61; P < .001). The incidence per 1000 person-years of any 1 of the 10 treatment-related complications was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.Conclusions and RelevanceThis cohort study found that, even after accounting for age-related symptoms and disease, PCA treatment was associated with higher rates of complications in the 12 years after treatment. Given the uncertain benefit of PCA treatment for most patients, these findings highlight the importance of patient counseling before PCA screening and treatment and provide a rationale for pursuing opportunities for cancer prevention.

中文翻译：

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前列腺癌治疗后的长期不良反应和并发症


重要性由于前列腺癌 （PCA） 通常具有惰性，因此治疗决策必须权衡癌症控制的风险和益处与治疗相关发病率的风险和益处。目的描述与一般老年男性人群相比，接受 PCA 治疗的患者的长期治疗相关不良反应和并发症。设计、设置和参与者这项队列研究使用了一种新颖的方法，将 2 项大型 PCA 预防临床试验（前列腺癌预防试验和硒和维生素 E 癌症预防试验）的数据与 Medicare 索赔记录联系起来。该分析包括接受前列腺切除术或放疗的 PCA 患者与未治疗的对照组的比较。使用多变量 Cox 回归，对 PCA 治疗的发生进行时变协变量，根据年龄、种族和风险开始年份进行调整，并按研究和干预组分层。数据分析于 2022 年 9 月 21 日至 2024 年 3 月 18 日进行。主要结局和措施从 Medicare 索赔数据中确定了 10 种潜在的 PCA 治疗相关并发症。结果研究样本包括 29 196 名参与者 （风险开始时的平均 [SD] 年龄，68.7 [4.8] 岁）。其中，3946 名参与者患有 PCA，其中 655 名接受了前列腺切除术治疗，1056 名接受了放疗。前列腺切除术患者的 12 年泌尿或性并发症风险高 7.23 倍 （95% CI，5.96-8.78;P < .001），放疗高 2.76 倍 （95% CI，2.26-3.37;P < .001） 与未治疗的参与者相比。 此外，在接受放疗治疗的参与者中，患膀胱癌的风险比未接受治疗的参与者高出近 3 倍（风险比 [HR]，2.78;95% CI，1.92-4.02;P < .001），以及包括放射性膀胱炎在内的辐射特异性结局的危险风险增加约 100 倍（HR，131.47;95% CI，52.48-329.35;P < .001） 和放射性直肠炎 （HR， 87.91;95% CI， 48.12-160.61;P < .001）。10 种治疗相关并发症中任何 1 种的每 1000 人年发生率为前列腺切除术 124.26 例，放疗 62.15 例，未治疗参与者 23.61 例。结论和相关性该队列研究发现，即使在考虑了与年龄相关的症状和疾病后，PCA 治疗与治疗后 12 年内较高的并发症发生率相关。鉴于 PCA 治疗对大多数患者的益处不确定，这些发现强调了在 PCA 筛查和治疗之前进行患者咨询的重要性，并为寻求癌症预防机会提供了理由。