患有局限性前列腺癌的男性可能会接受基于光子的调强放射治疗 (IMRT) 或质子束治疗 (PBT)。 PARTIQoL 试验 (NCT01617161) 证明了进行一项大型多中心 3 期随机试验的可行性，该试验比较 IMRT 与 PBT 对局限性前列腺癌的治疗效果。在这里，我们报告了参加本试验的患者的基线特征，并提出了提高其他类似试验可行性的策略。低风险或中风险前列腺癌患者被随机分配至 PBT 或 IMRT，并按机构、年龄、使用的分层进行分层。直肠间隔器和分割时间表（传统分割：44 次分割中 79.2 Gy 与中度大分割：28 次分割中 70.0 Gy）。主要终点是放射治疗后 24 个月使用扩张前列腺指数综合评分相对于基线肠道健康状况的变化。次要目标包括与治疗相关的泌尿和勃起功能差异、不良事件和疗效终点。2012 年 7 月至 2021 年 11 月期间，成功招募了 450 名患者。患者被随机分配接受 PBT (N = 226) 或 IMRT (N = 224)； 13人不符合资格或在治疗前退出。 437 名分析患者的中位年龄为 68 岁（范围：46-89 岁）。共有 41% 的患者患有低风险，59% 的患者患有中风险疾病。总共有 49% 的患者接受常规分割治疗，51% 的患者接受中度大分割治疗。 48% 的患者使用直肠垫片。对于接受 PBT 的患者，48% 使用笔形束扫描。 PBT 和 IMRT 组的基线变量是平衡的。尽管存在重大挑战，PARTIQoL 试验证明，通过有针对性的招募方法、多中心协作、付款人参与以及纳入当代技术的方案更新，进行大型 3 期随机临床是可行的评估 PBT 是否改善结果的试验。我们将单独报告主要结果，并继续监测参与者的长期随访和次要终点。版权所有 © 2024 Elsevier Inc. 保留所有权利。

Men with localized prostate cancer may receive either photon-based intensity modulated radiation therapy (IMRT) or proton beam therapy (PBT). The PARTIQoL trial (NCT01617161) demonstrates the feasibility of performing a large, multicenter phase 3 randomized trial comparing IMRT with PBT for localized prostate cancer. Here, we report baseline features of patients enrolled on this trial and present strategies to improve feasibility of other similar trials.Patients with low- or intermediate-risk prostate cancer were randomly assigned to either PBT or IMRT with stratification by institution, age, use of rectal spacer, and fractionation schedule (conventional fractionation: 79.2 Gy in 44 fractions vs moderate hypofractionation: 70.0 Gy in 28 fractions). The primary endpoint is a change from baseline bowel health using the Expanded Prostate Index Composite score 24 months after radiation therapy. Secondary objectives include treatment-related differences in urinary and erectile functions, adverse events, and efficacy endpoints.Between July 2012 and November 2021, 450 patients were successfully accrued. Patients were randomly assigned to either PBT (N = 226) or to IMRT (N = 224); 13 were ineligible or withdrew before treatment. The median age of 437 analyzed patients was 68 years (range, 46-89 years). A total of 41% of patients had low-risk and 59% had intermediate-risk disease. In total, 49% of patients were treated with conventional fractionation and 51% with moderately hypofractionation. 48% of patients used a rectal spacer. For patients receiving PBT, pencil beam scanning was used in 48%. PBT and IMRT arms were balanced for baseline variables.Despite significant challenges, the PARTIQoL trial demonstrated that, with targeted recruitment approaches, multicenter collaboration, payer engagement, and protocol updates to incorporate contemporary techniques, it is feasible to perform a large phase 3 randomized clinical trial to assess whether PBT improves outcomes. We will separately report primary results and continue to monitor participants for longer follow-up and secondary endpoints.Copyright © 2024 Elsevier Inc. All rights reserved.