在随机、单中心PKUFH第III期试验中，比较了剂量加强的（72 Gy）放射治疗与常规的（66 Gy）放射治疗。在之前的研究中，我们发现两组患者在4年生化进展无病存活（bPFS）方面没有显著差异。在当前的分析中，我们提供了7年的结果。将术后pT3-4期、手术切缘阳性或经过根治性前列腺切除术后前列腺特异性抗原增加≥0.2 ng/mL的患者随机分配为1:1，接受72 Gy in 36 fractions或66 Gy in 33 fractions的放射治疗。所有患者都接受了图像引导的调强放射治疗。主要终点是bPFS。次要终点是无远处转移生存（DMFS）、癌特异性生存（CSS）和总生存（OS），采用Kaplan-Meier方法评估这些终点。从2011年9月至2016年11月，共有144名患者参与了研究，其中72 Gy组和66 Gy组分别有73名和71名。在中位随访时间为89.5个月（范围：73-97个月）时，72 Gy组和66 Gy组的7年bPFS没有差异（70.3% vs 61.2%; 危险比 [HR] = 0.73, 95% 置信区间 [CI]: 0.41-1.29; P = 0.274）。然而，高Gleason评分（GS 8-10）的患者中，72 Gy组的7年bPFS与66 Gy组相比有显著改善（66.5% vs 30.2%; HR = 0.37, 95%CI: 0.17-0.82; P = 0.012）。此外，在多个阳性手术切缘（mSM+）的患者中，72 Gy组的7年bPFS与单个阳性手术切缘相比有显着改善（82.5% vs 57.5%; HR = 0.36, 95%CI: 0.13-0.99; P = 0.037）。72 Gy组和66 Gy组在7年DMFS（88.4% vs 84.9%; HR = 0.93, 95%CI: 0.39-2.23; P = 0.867）、CSS（94.1% vs 95.5%; HR = 1.19, 95%CI: 0.42-3.39; P = 0.745）和OS（92.8% vs 94.1%; HR = 1.29, 95%CI: 0.51-3.24; P = 0.594）方面没有统计学差异。当前的7年bPFS结果证实了我们以前的发现，剂量升级（72 Gy）与66 Gy方案相比在7年bPFS、DMFS、CSS或OS方面没有改善。然而，高GS（8-10）或mSM+的患者可能会从72 Gy方案中受益，但这需要进一步前瞻性研究。版权所有©2023. 由Elsevier Inc.出版。

In the randomized, single-center, PKUFH phase III trial, dose-intensified (72 Gy) radiation therapy was compared with conventional (66 Gy) radiation therapy. In a previous study, we found no significant difference in biochemical progression-free survival (bPFS) between the two cohorts at 4 years. In the current analysis, we provide 7-year outcomes.Patients with stage pT3-4, positive surgical margins, or prostate-specific antigen increase ≥0.2 ng/mL after radical prostatectomy were randomly assigned 1:1 to receive either 72 Gy in 36 fractions or 66 Gy in 33 fractions. All the patients underwent image-guided intensity-modulated radiotherapy. The primary end point was bPFS. Secondary end points were distant metastasis-free survival (DMFS), cancer-specific survival (CSS), and overall survival (OS), as estimated using the Kaplan-Meier method.Between September 2011 and November 2016, 144 patients were enrolled, with 73 and 71 in the 72 and 66 Gy cohorts, respectively. At a median follow-up of 89.5 months (range, 73-97 months), there was no difference in 7-year bPFS between the 72 and 66 Gy cohorts (70.3% vs 61.2%; hazard ratio [HR] = 0.73, 95% confidence interval [CI]: 0.41-1.29; P = 0.274). However, in patients with a higher Gleason score (GS 8-10), the 72 Gy cohort had statistically significant improvement in 7-year bPFS compared with the 66 Gy cohort (66.5% vs 30.2%; HR = 0.37, 95%CI: 0.17-0.82; P = 0.012). In addition, in patients with multiple positive surgical margins (mSM+), the 72 Gy cohort had statistically significant improvement in 7-year bPFS compared with single positive surgical margin (82.5% vs 57.5%; HR = 0.36, 95%CI: 0.13-0.99; P = 0.037). The 7-year DMFS (88.4% vs 84.9%; HR = 0.93, 95%CI: 0.39-2.23; P = 0.867), CSS (94.1% vs 95.5%; HR = 1.19, 95%CI: 0.42-3.39; P = 0.745), and OS (92.8% vs 94.1%; HR = 1.29, 95%CI: 0.51-3.24; P = 0.594) had no statistically difference between the 72 and 66 Gy cohorts.The current 7-year bPFS results confirmed our previous findings that dose escalation (72 Gy) demonstrated no improvement in 7-year bPFS, DMFS, CSS, or OS compared to the 66 Gy regimen. However, patients with a higher GS (8-10) or mSM+ might benefit from the 72 Gy regimen, but this requires further prospective research.Copyright © 2023. Published by Elsevier Inc.