Département de radio-oncologie, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Québec, Canada.
Département de radio-oncologie, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, Québec, Canada.
Int J Radiat Oncol Biol Phys. 2023 Jul 15;116(4):779-787. doi: 10.1016/j.ijrobp.2022.12.055. Epub 2023 Jan 11.
Prostate-specific membrane antigen (PSMA) ligand positron emission tomography (PET) is increasingly integrated in prostate cancer management because of its diagnostic performance. We sought to evaluate the effect of PSMA-PET/computed tomography (CT)-guided intensification of radiation therapy (PSMAgRT) on patient outcomes. Here, we report secondary trial endpoints including the rate of new lesion detection, effect on prostate cancer management, and treatment-related toxicities.
In this phase 2 cohort multiple randomized controlled trial across 2 institutions, men with prostate cancer planned for RT were randomly selected for PSMAgRT across 4 strata: oligometastatic, high risk (Cancer of the Prostate Risk Assessment ≥6 or cN1), salvage post-RT, and salvage postprostatectomy (RP). Primary endpoint was failure-free survival at 5 years, with analysis pending further follow-up. Secondary endpoints included new lesion detection yield of PSMA-PET/CT, acute and delayed toxicities, effect on prostate cancer management, and health-related quality-of-life outcomes. This trial is registered with ClinicalTrials.gov, identifier NCT03525288, companion to registry NCT03378856.
Between May 2018 and February 2021, 262 patients were enrolled and randomized. Nine patients were later excluded (5 control, 4 PSMAgRT), leaving 253 patients for analysis (23 oligometastatic, 86 high risk, 16 salvage post-RT, and 128 salvage post-RP). New lesions were detected in 45.5% of oligometastatic, 39.5% of high risk, 14.3% of salvage post-RT, and 51.6% of salvage post-RP. Overall, PSMA-PET/CT led to intensification of RT in over half of patients (52.0%), with minimal intensification of systemic therapy (4.0%). With a median follow-up of 12.9 months, this intensification was associated with 3 attributable grade 3+ events (2.5% of patients undergoing PSMAgRT) but no difference in the rate of grade 2+ events attributable to RT compared with controls (43%, both arms).
In this randomized trial, PSMA-PET/CT led to intensification of RT in more than half of patients. Longer follow-up is required to determine whether this intensification translates to effect on cancer control and long-term toxicity and health-related quality-of-life outcomes.
由于前列腺特异性膜抗原（PSMA）配体正电子发射断层扫描（PET）具有诊断性能，因此在前列腺癌管理中越来越多地整合了这种方法。我们旨在评估 PSMA-PET/计算机断层扫描（CT）引导的放疗强化（PSMAgRT）对患者结局的影响。在此，我们报告了次要试验终点，包括新病灶检出率、对前列腺癌管理的影响以及治疗相关毒性。
在这一来自 2 家机构的 2 期队列、多中心、随机对照试验中，计划接受放疗的前列腺癌患者被随机分为 4 个亚组进行 PSMAgRT：寡转移、高危（前列腺癌风险评估≥6 或 cN1）、挽救性 post-RT 和挽救性 postprostatectomy（RP）。主要终点是 5 年无失败生存，在进一步随访前进行分析。次要终点包括 PSMA-PET/CT 的新病灶检出率、急性和迟发性毒性、对前列腺癌管理的影响以及健康相关生活质量结局。该试验在 ClinicalTrials.gov 注册，标识符为 NCT03525288，配套注册号为 NCT03378856。
在 2018 年 5 月至 2021 年 2 月期间，共纳入 262 例患者并进行了随机分组。9 例患者随后被排除（5 例对照组，4 例 PSMAgRT 组），253 例患者纳入分析（23 例寡转移，86 例高危，16 例挽救性 post-RT，128 例挽救性 post-RP）。寡转移组中有 45.5%、高危组中有 39.5%、挽救性 post-RT 组中有 14.3%、挽救性 post-RP 组中有 51.6%的患者检测到新病灶。总体而言，PSMA-PET/CT 导致超过一半的患者（52.0%）进行了放疗强化，仅有 4.0%的患者进行了系统治疗的最小强化。中位随访 12.9 个月时，这种强化与 3 例归因于 3 级+的事件相关（2.5%的接受 PSMAgRT 的患者），但与对照组相比，归因于 RT 的 2 级+事件发生率无差异（43%，两组）。
在这项随机试验中，PSMA-PET/CT 导致超过一半的患者进行了放疗强化。需要更长时间的随访，以确定这种强化是否转化为对癌症控制和长期毒性及健康相关生活质量结局的影响。
