■之前没有试验将大分割前列腺切除术后放疗(HYPORT)与常规分割前列腺切除术后放疗(COPORT)在主要接受前列腺切除术治疗的患者中进行比较。
■确定患者报告的泌尿生殖系统(GU)和胃肠道(GI)症状在2年内HYPORT是否不劣于COPORT。
■在这项3期随机临床试验中,在前列腺切除术后可检测到前列腺特异性抗原(PSA;≥0.1ng/mL)伴pT2/3pNX/0疾病或无法检测到PSA(<0.1ng/mL)伴pT3疾病或pT2疾病且手术切缘阳性的患者来自93名学者,以社区为基础,以及美国和加拿大的三级医疗场所。在2017年6月至2018年7月期间,共有296名患者被随机分组。数据在2020年12月进行了分析,并根据需要在之后进行了其他分析。
■患者随机接受25个部分的62.5Gy(HYPORT)或37个部分的66.6Gy(COPORT)。
■主要终点是前列腺癌综合指数扩大问卷的肠和尿领域评分与基线的2年变化。次要目标是比较武器免受生化失败的情况,进步的时间,局部故障,区域失败,抢救疗法,远处转移,前列腺癌特异性生存率,总生存率,和不良事件。
■在随机分组的296名患者中(中位[范围]年龄,65[44-81]岁;100%男性),144收到HYPORT和152收到COPORT。在RT结束时,HYPORT和COPORT组的平均GU变化评分在6个月和12个月时无临床意义,也无统计学差异.HYPORT和COPORT的平均(SD)GI变化评分均具有临床意义,并且在RT结束时具有统计学意义(-15.52[18.43]和-7.06[12.78],分别;P<.001)。然而,在6个月和12个月时,HYPORT和COPORT平均GI变化评分的临床和统计学显著差异得到解决.HYPORT的平均GU和GI变化评分的24个月差异分别为-5和-6,与COPORT相比不差。拒绝自卑的零假设(平均[SD]GU得分:HYPORT,-5.01[15.10]和COPORT,-4.07[14.67];P=.005;平均[SD]GI评分:HYPORT,-4.17[10.97]和COPORT,-1.41[8.32];P=.02)。审查患者的中位随访时间为2.1年,HYPORT与COPORT在生化衰竭方面没有差异,定义为PSA为0.4ng/mL或更高,并在上升(2年期,12%对8%;P=.28)。
■在这项随机临床试验中,与RT完成时的COPORT相比,HYPORT与患者报告的胃肠道毒性作用更大相关。但两组均在6个月内恢复至基线水平.在2年,就患者报告的GU或胃肠道毒性作用而言,HYPORT不劣于COPORT。HYPORT是接受前列腺切除术后放疗的患者的新的可接受的实践标准。
■ClinicalTrials.gov标识符:NCT03274687。
UNASSIGNED: No prior trial has compared hypofractionated postprostatectomy radiotherapy (HYPORT) to conventionally fractionated postprostatectomy (COPORT) in patients primarily treated with prostatectomy.
UNASSIGNED: To determine if HYPORT is noninferior to COPORT for patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms at 2 years.
UNASSIGNED: In this phase 3 randomized clinical trial, patients with a detectable prostate-specific antigen (PSA; ≥0.1 ng/mL) postprostatectomy with pT2/3pNX/0 disease or an undetectable PSA (<0.1 ng/mL) with either pT3 disease or pT2 disease with a positive surgical margin were recruited from 93 academic, community-based, and tertiary medical sites in the US and Canada. Between June 2017 and July 2018, a total of 296 patients were randomized. Data were analyzed in December 2020, with additional analyses occurring after as needed.
UNASSIGNED: Patients were randomized to receive 62.5 Gy in 25 fractions (HYPORT) or 66.6 Gy in 37 fractions (COPORT).
UNASSIGNED: The coprimary end points were the 2-year change in score from baseline for the bowel and urinary domains of the Expanded Prostate Cancer Composite Index questionnaire. Secondary objectives were to compare between arms freedom from biochemical failure, time to progression, local failure, regional failure, salvage therapy, distant metastasis, prostate cancer-specific survival, overall survival, and adverse events.
UNASSIGNED: Of the 296 patients randomized (median [range] age, 65 [44-81] years; 100% male), 144 received HYPORT and 152 received COPORT. At the end of RT, the mean GU change scores among those in the HYPORT and COPORT arms were neither clinically significant nor different in statistical significance and remained so at 6 and 12 months. The mean (SD) GI change scores for HYPORT and COPORT were both clinically significant and different in statistical significance at the end of RT (-15.52 [18.43] and -7.06 [12.78], respectively; P < .001). However, the clinically and statistically significant differences in HYPORT and COPORT mean GI change scores were resolved at 6 and 12 months. The 24-month differences in mean GU and GI change scores for HYPORT were noninferior to COPORT using noninferiority margins of -5 and -6, respectively, rejecting the null hypothesis of inferiority (mean [SD] GU score: HYPORT, -5.01 [15.10] and COPORT, -4.07 [14.67]; P = .005; mean [SD] GI score: HYPORT, -4.17 [10.97] and COPORT, -1.41 [8.32]; P = .02). With a median follow-up for censored patients of 2.1 years, there was no difference between HYPORT vs COPORT for biochemical failure, defined as a PSA of 0.4 ng/mL or higher and rising (2-year rate, 12% vs 8%; P = .28).
UNASSIGNED: In this randomized clinical trial, HYPORT was associated with greater patient-reported GI toxic effects compared with COPORT at the completion of RT, but both groups recovered to baseline levels within 6 months. At 2 years, HYPORT was noninferior to COPORT in terms of patient-reported GU or GI toxic effects. HYPORT is a new acceptable practice standard for patients receiving postprostatectomy radiotherapy.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03274687.