METHODS: In this non-randomized trial, men with unfavorable intermediate or high-risk prostate cancer, aged ≥70 years or with Charlson Comorbidity Index ≥2, were treated with RT (78-79.2 Gy in 39-44 fractions) and either oral ADT (oADT; 5-ARI with antiandrogen) or standard of care ADT (SOC; leuprolide with antiandrogen) for up to 28 months. The primary endpoint was EPIC hQOL; secondary endpoints included biochemical control and survival as well as changes in cholesterol and hemoglobin levels.
RESULTS: Between 2011 and 2018, 70 men were enrolled (40 in oADT; 30 in SOC). Median follow-up was 65 months [IQR 36-94]. Five-year freedom from biochemical failure for oADT and SOC was 89% versus 86%, disease free survival was 62% versus 69%, cancer-specific survival was 100% versus 96%, and overall survival was 70% versus 81% (all P>.1). Testosterone (2 mo through 3 yr) and hemoglobin levels (2 mo through 2 yr) were higher, and cholesterol levels (1 yr) were lower in the oADT groups (all P < .05).
CONCLUSIONS: In this non-randomized study, men treated with combined RT and oADT had better preservation of hQOL and comparable 5-year disease outcomes to men treated with SOC. Eugonadal testosterone with this approach may yield measurable benefits in cholesterol and hemoglobin levels.
方法:在这项非随机试验中,患有不利的中度或高风险前列腺癌的男性,年龄≥70岁或Charlson合并症指数≥2的患者接受RT(78-79.2Gy/39-44分)和口服ADT(oADT;5-ARI+抗雄激素)或标准治疗ADT(SOC;亮丙瑞林+抗雄激素)治疗长达28个月.主要终点是EPIChQOL;次要终点包括生化控制和生存率以及胆固醇和血红蛋白水平的变化。
结果:在2011年至2018年之间,招募了70名男性(oADT40名;SOC30名)。中位随访时间为65个月[IQR36-94]。oADT和SOC的五年生化失败发生率分别为89%和86%,无病生存率分别为62%和69%,癌症特异性生存率为100%对96%,总生存率分别为70%和81%(均P>1)。睾酮(2个月至3年)和血红蛋白水平(2个月至2年)较高,oADT组的胆固醇水平(1年)较低(均P<0.05)。
结论:在这项非随机研究中,与接受SOC治疗的男性相比,接受RT和oADT联合治疗的男性对hQOL的保留效果更好,且5年疾病结局具有可比性.使用这种方法的Euggonadal睾丸激素可能会在胆固醇和血红蛋白水平方面产生可测量的益处。