Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
Department of Oncology, London Health Sciences Centre, Western University, London, ON, Canada.
BMC Cancer. 2022 Mar 8;22(1):251. doi: 10.1186/s12885-022-09283-z.
Positron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer.
This pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6-10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained.
This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective.
This trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.
针对前列腺特异性膜抗原（PSMA PET/CT）的正电子发射断层扫描（PET）已被证明在前列腺癌分期检查方面具有无与伦比的性能，导致治疗管理发生了重大变化。然而，改变管理对患者结局的影响在很大程度上尚不清楚。本研究旨在评估 PSMA PET/CT 引导的强化放疗或手术对高危前列腺癌患者的影响。
这项全加的 III 期随机对照试验将招募 776 名未经治疗的高危前列腺癌（CAPRA 评分 6-10 或 cN1 期）或根治性前列腺切除术后生化复发的前列腺癌患者（PSA>0.1ng/mL）。患者将按 1:1 随机分为常规影像学检查或常规加 PSMA PET 影像学检查，对新发现的疾病部位进行强化放疗或手术。主要终点是 5 年无失败生存率。次要终点包括不良事件发生率、下一线治疗时间，以及对健康相关生活质量和成本效益的影响，以增量成本每获得的质量调整生命年来衡量。
这项研究将有助于提供一级证据，以证明基于 PSMA PET 结果强化放疗或手术是否以具有成本效益的方式改善高危前列腺癌患者的结局。
该试验于 2020 年 9 月 21 日在 ClinicalTrials.gov 前瞻性注册为 NCT04557501。
