BACKGROUND No standard therapy has been established for localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP). OBJECTIVE To determine whether radiotherapy ± hormone therapy is superior to hormone therapy alone in such patients. DESIGN, SETTING, AND PARTICIPANTS This study is a multicentre, randomised, open-label, phase 3 trial. Patients with localised prostate cancer whose PSA concentrations had decreased to <0.1 ng/ml after RP, and then increased to 0.4-1.0 ng/ml, were randomised to the salvage hormone therapy (SHT) group (80 mg bicalutamide [BCL] followed by luteinising hormone-releasing hormone agonist in case of BCL failure) or the salvage radiation therapy (SRT) ± SHT group (64.8 Gy of SRT followed by the same regimen as in the SHT group in case of SRT failure). From May 2004 to May 2011, 210 patients (105 in each arm) were registered, with the median follow-up being 5.5 yr. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary endpoint was time to treatment failure (TTF) of BCL. RESULTS AND LIMITATIONS TTF of BCL was significantly longer in the SRT ± SHT group (8.6 yr) than in the SHT group (5.6 yr; hazard ratio 0.56, 90% confidence interval [0.40-0.77]; one-sided p =  0.001). Thirty-two of 102 patients (31%) in the SRT ± SHT group did not have SRT treatment failure. However, clinical relapse-free survival and overall survival did not differ between the arms. The most frequent grade 3-4 adverse event was erectile dysfunction (83 patients [80%] in the SHT group vs. 76 [74%] in the SRT ± SHT group). Limitations include the short follow-up periods and surrogate endpoint setting to allow definitive conclusions. CONCLUSIONS Initial SRT prolongs TTF of BCL in patients with post-RP PSA failure, indicating that SRT ± SHT is more beneficial than SHT alone. PATIENT SUMMARY Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy.

中文翻译：

---

根治性前列腺切除术后前列腺特异性抗原衰竭的挽救性放疗与激素治疗：一项随机，多中心，开放标签的3期试验（JCOG0401）†。

背景技术对于根治性前列腺切除术（RP）后具有前列腺特异性抗原（PSA）衰竭的局限性前列腺癌患者，尚未建立标准疗法。目的确定在此类患者中放疗±激素疗法是否优于单独的激素疗法。设计，地点和参与者该研究是一项多中心，随机，开放标签的3期临床试验。RP后PSA浓度降至<0.1 ng / ml，然后升高至0.4-1.0 ng / ml的局限性前列腺癌患者被随机分为抢救激素治疗（SHT）组（80 mg比卡鲁胺[BCL]黄体生成素释放激素激动剂（如果发生BCL失败）或挽救放疗（SRT）±SHT组（SRT失败时，SRT组为64.8 Gy，随后采取与SHT组相同的方案）。从2004年5月至2011年5月，登记了210例患者（每组105例），中位随访时间为5.5年。结果测量和统计分析主要终点是BCL的治疗失败时间（TTF）。结果与局限性SRT±SHT组（8.6年）的BCL TTF明显长于SHT组（5.6年；危险比0.56，90％置信区间[0.40-0.77]；单面p = 0.001）。SRT±SHT组中102例患者中有32例（31％）没有SRT治疗失败。但是，两组之间的临床无复发生存期和总生存期没有差异。最常见的3-4级不良事件是勃起功能障碍（SHT组为83例[80％]，而SRT±SHT组为76例[74％]）。局限性包括随访时间短和替代终点设定，以得出明确的结论。结论最初的SRT延长了RP PSA衰竭患者的BCL的TTF，这表明SRT±SHT比单独的SHT更有益。患者总结前列腺癌根治术后发生前列腺特异性抗原衰竭的患者可在抢救激素治疗之前受益于抢救放疗。