Department of Urology, OLVG, Amsterdam, The Netherlands; Department of Urology, VU university Medical Centre, Amsterdam, The Netherlands.
Department of Radiotherapy, Academic Medical Centre, Amsterdam, The Netherlands.
Eur Urol. 2019 Mar;75(3):410-418. doi: 10.1016/j.eururo.2018.09.008. Epub 2018 Sep 25.
The cornerstone of standard treatment for patients with primary bone metastatic prostate cancer (mPCa) is androgen deprivation therapy (ADT). Retrospective studies suggest a survival benefit for treatment of the primary prostatic tumour in mPCa, but to date, no randomised-controlled-trials (RCTs) have been published addressing this issue.
To determine whether overall survival is prolonged by adding local treatment of the primary prostatic tumour with external beam radiation therapy (EBRT) to ADT.
DESIGN, SETTING, AND PARTICIPANTS: The HORRAD trial is a multicentre RCT recruiting 432 patients with prostate-specific antigen (PSA) >20ng/ml and primary bone mPCa on bone scan between 2004 and 2014.
Patients were randomised to either ADT with EBRT (radiotherapy group) or ADT alone (control group).
Primary endpoint was overall survival. Secondary endpoint was time to PSA progression. Crude and adjusted analyses were applied to evaluate treatment effect.
Median PSA level was 142ng/ml and 67% of patients had more than five osseous metastases. Median follow up was 47 mo. Median overall survival was 45 mo (95% confidence interval [CI], 40.4-49.6) in the radiotherapy group and 43 mo (95% CI: 32.6-53.4) in the control group (p=0.4). No significant difference was found in overall survival (hazard ratio [HR]: 0.90; 95% CI: 0.70-1.14; p=0.4). Median time to PSA progression in the radiotherapy group was 15 mo (95% CI: 11.8-18.2), compared with 12 mo (95% CI: 10.6-13.4) in the control group. The crude HR (0.78; 95% CI: 0.63-0.97) was statistically significant (p=0.02).
The current RCT comparing ADT to ADT with EBRT to the prostate in patients with primary bone mPCa did not show a significant difference in overall survival, although the CI cannot exclude a substantial survival benefit. Further research is needed to confirm our findings.
This study investigated the effect of adding radiation therapy to the prostate to hormonal therapy in prostate cancer patients with metastasis to the bone at diagnosis. In our patient group, additional radiotherapy did not improve overall survival. Further research is needed to confirm our findings.
Adding radiotherapy to the prostate in patients with bone metastatic prostate cancer does not improve overall survival.
对于原发性骨转移前列腺癌（mPCa）患者，标准治疗的基石是雄激素剥夺疗法（ADT）。回顾性研究表明，mPCa 中前列腺原发肿瘤的治疗有生存获益，但迄今为止，尚无发表的随机对照试验（RCT）对此问题进行探讨。
确定在 ADT 的基础上，加用外部束放射治疗（EBRT）治疗前列腺原发肿瘤是否能延长总体生存期。
设计、地点和参与者：HORRAD 试验是一项多中心 RCT，于 2004 年至 2014 年间入组了 432 名前列腺特异性抗原（PSA）＞20ng/ml 且骨扫描显示原发性骨 mPCa 的患者。
患者被随机分配至 ADT 加 EBRT（放疗组）或 ADT 单药治疗（对照组）。
主要终点为总生存期。次要终点为 PSA 进展时间。采用粗分析和校正分析来评估治疗效果。
中位 PSA 水平为 142ng/ml，67%的患者有超过 5 处骨转移。中位随访时间为 47 个月。放疗组中位总生存期为 45 个月（95%置信区间[CI]：40.4-49.6），对照组为 43 个月（95% CI：32.6-53.4）（p=0.4）。两组总生存期无显著差异（风险比[HR]：0.90；95% CI：0.70-1.14；p=0.4）。放疗组 PSA 进展时间的中位值为 15 个月（95% CI：11.8-18.2），对照组为 12 个月（95% CI：10.6-13.4）。粗 HR（0.78；95% CI：0.63-0.97）有统计学意义（p=0.02）。
目前这项 RCT 比较了 ADT 联合与不联合 EBRT 治疗前列腺原发肿瘤对原发性骨转移前列腺癌患者的疗效，结果显示在总生存期方面无显著差异，尽管 CI 不能排除生存获益的可能性。需要进一步的研究来证实我们的发现。
这项研究调查了在诊断时发生骨转移的前列腺癌患者中，将放射治疗加于前列腺对激素治疗的效果。在我们的患者群体中，额外的放疗并没有改善总体生存率。需要进一步的研究来证实我们的发现。
在骨转移前列腺癌患者中，将放射治疗加于前列腺并不能改善总体生存率。
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