Wisdom Amy J, Yeap Beow Y, Michalski Jeff M, Horick Nora K, Zietman Anthony L, Christodouleas John P, Kamran Sophia C, Parikh Rahul R, Vapiwala Neha, Mihalcik Stephen, Miyamoto David T, Zeng Jing, Gay Hiram A, Pisansky Thomas M, Mishra Mark V, Spratt Daniel E, Mendenhall Nancy P, Soffen Edward M, Bekelman Justin E, Efstathiou Jason A
Department Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Department Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):741-751. doi: 10.1016/j.ijrobp.2024.09.043. Epub 2024 Sep 30.
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.
局限性前列腺癌男性患者可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）证明了开展一项大型多中心3期随机试验的可行性，该试验比较IMRT与PBT治疗局限性前列腺癌的效果。在此，我们报告参与该试验患者的基线特征，并提出提高其他类似试验可行性的策略。
低危或中危前列腺癌患者被随机分配至PBT组或IMRT组，按机构、年龄、是否使用直肠间隔器和分割方案进行分层（常规分割：44次分割，总剂量79.2 Gy；适度超分割：28次分割，总剂量70.0 Gy）。主要终点是放疗24个月后使用扩展前列腺指数综合评分评估的肠道健康自基线的变化。次要目标包括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例患者。患者被随机分配至PBT组（N = 226）或IMRT组（N = 224）；13例不符合条件或在治疗前退出。437例分析患者的中位年龄为68岁（范围46 - 89岁）。共有41%的患者为低危疾病，59%为中危疾病。总体而言，49%的患者接受常规分割治疗，51%接受适度超分割治疗。48%的患者使用直肠间隔器。接受PBT的患者中，48%采用笔形束扫描。PBT组和IMRT组的基线变量均衡。
尽管面临重大挑战，但PARTIQoL试验表明，通过有针对性的招募方法、多中心协作、医保机构参与以及纳入当代技术的方案更新，开展一项大型3期随机临床试验以评估PBT是否能改善结局是可行的。我们将另行报告主要结果，并继续对参与者进行更长时间的随访和次要终点监测。
