Biochemical outcome in metastatic prostate cancer patients following prostate-directed radiotherapy

ecancermedicalscience Pub Date : 2024-03-26 DOI:10.3332/ecancer.2024.1686

Heba Maged Ayoub, F. M. Elsayed, M. Zamzam, Ihab M.A. Hassanin, Eman Essam Elsemary

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Abstract

Background The role of cytoreductive local radiotherapy (RT) in metastatic prostate cancer (mPCa) has recently been established. This study aimed to evaluate the biochemical outcome of local RT in mPCa. Methods This randomised controlled phase III study was conducted at the Clinical Oncology Department, Suez Canal University Hospital. Eligible participants were de-novo or metachronous mPCa patients with Eastern Cooperative Oncology Group performance status of 0–2. Participants were randomised to receive either cytoreductive prostate-directed RT in addition to standard care or standard care alone. The conventional radiation schedule of 70 Gy/35 fractions or the hypofractionated schedule of 55 Gy/20 fractions were delivered. The primary endpoint was biochemical progression-free survival (BPFS), and the secondary endpoint was overall survival (OS). Survival and post-hoc analyses were performed using Cox regression and the Kaplan-Meier method with the log-rank test. Results Between 23 November 2020 and 21 2022, 70 patients were enrolled in this study. Of them, 34 patients were assigned to the prostate RT group, and 29 patients were assigned to the control group. At a median follow-up of 12 months, the median BPFS has not been reached for the prostate RT group compared to 4.067 months for the control group (HR: 0.147, p < 0.001). Subgroup analysis showed that the median BPFS was statistically significantly correlated with low-volume (95% CI, 0.004 to 0.262, p = 0·001) and hormonal-sensitive metastatic disease (95% CI, 0.010 to 0.192, p < 0·001). The median OS was 16.33 months for the prostate-RT group compared to 11.33 months for the control group (HR: 0.313, p = 0.003). Conclusion Prostate-directed RT improved BPFS and OS in mPCa patients, particularly in those with low volume and hormonal-sensitive disease. Trial Registration This trial is registered on (27/4/2023), retrospectively registered with pactr.samrc.ac.za, PACTR202305854600529, URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25510

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前列腺导向放射治疗后转移性前列腺癌患者的生化结果

背景近来，细胞杀伤性局部放射治疗（RT）在转移性前列腺癌（mPCa）中的作用已得到确立。本研究旨在评估局部 RT 对转移性前列腺癌的生化疗效。方法这项随机对照 III 期研究在苏伊士运河大学医院临床肿瘤科进行。符合条件的参与者均为东部合作肿瘤学组（Eastern Cooperative Oncology Group）表现状态为0-2级的新发或晚期mPCa患者。参试者被随机分配接受除标准治疗外的前列腺定向放射治疗或单独接受标准治疗。采用70 Gy/35次的常规放射治疗计划或55 Gy/20次的低分次放射治疗计划。主要终点是无生化进展生存期（BPFS），次要终点是总生存期（OS）。生存期分析和事后分析采用 Cox 回归法和 Kaplan-Meier 法，并进行对数秩检验。结果 2020年11月23日至2022年11月21日期间，70名患者参与了这项研究。其中，34 名患者被分配到前列腺 RT 组，29 名患者被分配到对照组。在中位随访12个月时，前列腺RT组的中位BPFS尚未达到，而对照组为4.067个月（HR：0.147，P<0.001）。亚组分析显示，中位BPFS与低体积（95% CI, 0.004 to 0.262, p = 0-001）和激素敏感性转移性疾病（95% CI, 0.010 to 0.192, p < 0-001）有显著统计学相关性。前列腺定向 RT 组的中位 OS 为 16.33 个月，对照组为 11.33 个月（HR：0.313，P = 0.003）。结论前列腺定向 RT 可改善 mPCa 患者的 BPFS 和 OS，尤其是对低体积和激素敏感的患者。试验注册本试验注册日期为（2023年4月27日），在pactr.samrc.ac.za进行了回顾性注册，PACTR202305854600529，网址：https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25510。

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