AIM To report toxicity and quality of life (QOL) outcomes from a randomised trial of prostate only versus whole pelvic radiotherapy in high risk, node negative prostate cancer. MATERIALS/METHODS Patients with localised prostate adenocarcinoma and nodal involvement risk > 20%, were randomised to prostate only (PORT, 68 Gy/25# to prostate) and whole pelvis (WPRT, 68 Gy/25# to prostate and 50 Gy/25# to pelvis) arms with stratification for TURP, Gleason score, baseline PSA, and type of androgen deprivation therapy (ADT). Image guided intensity modulated radiotherapy (IG-IMRT) and two years of ADT were mandatory. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities were graded using RTOG grading. QOL was assessed using EORTC QLQ-C30 and PR-25 questionnaire pre-treatment and every 3-6 months post RT. RESULTS Total 224 patients were randomised (PORT 114, WPRT 110) from November 2011 to August 2017. Median follow up was 44.5 months. No RTOG grade IV toxicity was observed. Acute GI and GU toxicities were similar between both the arms. Cumulative ≥ grade II late GI toxicity was similar for WPRT and PORT (6.5% vs. 3.8%, p = 0.39) but GU toxicity was higher (17.7% vs. 7.5%, p = 0.03). Dosimetric analysis showed higher bladder volume receiving 30-40 Gy in the WPRT arm (V30, 60% vs. 36%, p < 0.001; V40, 41% vs. 25%, p < 0.001). There was no difference in QOL scores of any domain between both arms. CONCLUSION Pelvic irradiation using hypofractionated IG-IMRT resulted in increased grade II or higher late genitourinary toxicity as compared to prostate only RT, but the difference was not reflected in patient reported QOL. CLINICALTRIALS.GOV NCT02302105: Prostate Only or Whole Pelvic Radiation Therapy in High Risk Prostate Cancer (POP-RT).

中文翻译：

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高危前列腺癌 (POP-RT) 仅前列腺或全盆腔放射治疗的晚期毒性和生活质量：一项随机试验

目的 报告一项随机试验的毒性和生活质量 (QOL) 结果，该试验在高风险、淋巴结阴性的前列腺癌中进行了仅前列腺与全盆腔放疗的对比。材料/方法 局限性前列腺癌和淋巴结受累风险 > 20% 的患者随机分为仅前列腺（PORT，68 Gy/25# 前列腺）和整个骨盆（WPRT，68 Gy/25# 前列腺和 50 Gy/25 # 到骨盆）对 TURP、格里森评分、基线 PSA 和雄激素剥夺疗法 (ADT) 类型进行分层的手臂。图像引导的调强放疗 (IG-IMRT) 和两年的 ADT 是强制性的。使用 RTOG 分级对急性和晚期泌尿生殖 (GU) 和胃肠 (GI) 毒性进行分级。在治疗前和放疗后每 3-6 个月使用 EORTC QLQ-C30 和 PR-25 问卷评估 QOL。结果 从 2011 年 11 月到 2017 年 8 月，共有 224 名患者被随机分组​​（PORT 114，WPRT 110）。中位随访时间为 44.5 个月。未观察到 RTOG IV 级毒性。两组之间的急性 GI 和 GU 毒性相似。WPRT 和 PORT 的累积≥ II 级晚期 GI 毒性相似（6.5% 对 3.8%，p = 0.39），但 GU 毒性更高（17.7% 对 7.5%，p = 0.03）。剂量学分析显示 WPRT 组接受 30-40 Gy 的膀胱容量更高（V30，60% 对 36%，p < 0.001；V40，41% 对 25%，p < 0.001）。两组之间任何领域的 QOL 得分都没有差异。结论 与仅前列腺放疗相比，使用大分割 IG-IMRT 进行盆腔照射会导致 II 级或更高的晚期泌尿生殖毒性，但这种差异并未反映在患者报告的 QOL 中。临床试验。