研究动态
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DIPPER 试验方案:一项多中心、随机的试验,比较根治性前列腺切除术后生化复发患者的保守观察与放射治疗的疗效(ANZUP 2002)。

DIPPER trial protocol: A multi-centre, randomised trial of salvage radiotherapy versus surveillance for biochemical recurrence after radical prostatectomy (ANZUP 2002).

发表日期:2023 Aug 21
作者: Matthew J Roberts, Ciara Conduit, Ian D Davis, Rachel M Effeney, Scott Williams, Jarad M Martin, Michael S Hofman, George Hruby, Renu Eapen, Chris Gianacas, Nathan Papa, Richard De Abreu Lourenço, Haryana M Dhillon, Ray Allen, Antoinette Fontela, Baldeep Kaur, Louise Emmett,
来源: BJU INTERNATIONAL

摘要:

低风险前列腺特异性抗原(PSA)复发的挽救性放疗和监测存在竞争风险和利益。 目前尚不清楚在根治性前列腺切除术后PSA复发且前列腺特异性膜抗原-正电子发射断层扫描/计算机断层扫描(PSMA-PET/CT)未显示明确复发疾病的情况下,早期前列腺床和骨盆淋巴结挽救性放疗与监测相比的有效性。 "前列腺切除术后放疗结果改善的特定成像(DIPPER)"是一项开放标签的多中心随机2期试验。主要终点是3年无事件生存,事件包括PSA复发(PSA≥基线值的0.2ng/mL),放射学证据的转移性疾病,或开始系统性或其他恢复性治疗。次要终点包括患者报告结果,治疗模式,参与者感知和费用效果。符合条件的参与者是指根据修正的欧洲泌尿学协会(EAU)生化复发风险标准(ISUP级别组≤2,PSA翻倍时间超过12个月)定义的前列腺癌PSA复发,血清PSA为0.2-0.5ng/mL,且在PSMA-PET/CT上没有明确的/可能的复发前列腺癌。版权所有,未经授权,不得转载。
Salvage radiation therapy and surveillance for low risk PSA recurrence have competing risks and benefits. The efficacy of early salvage radiation therapy to the prostate bed with or without pelvic lymph nodes compared to surveillance in patients with prostate specific antigen (PSA) recurrence following radical prostatectomy and no identifiable recurrent disease evident on prostate specific membrane antigen-positron emission tomography/computerised tomography (PSMA-PET/CT) is unknown.Dedicated Imaging Post-Prostatectomy for Enhanced Radiotherapy outcomes (DIPPER) is an open-label, multi-centre, randomised phase 2 trial.The primary endpoint is 3-year event-free survival, with events comprising one of PSA recurrence (PSA ≥0.2ng/mL higher than baseline), radiologic evidence of metastatic disease or initiation of systemic or other salvage treatments. Secondary endpoints include patient reported outcomes, treatment patterns, participant perceptions and cost-effectiveness.Eligible participants have PSA recurrence of prostate cancer following radical prostatectomy, defined by serum PSA 0.2-0.5ng/mL, deemed low risk according to modified European Association of Urology (EAU) biochemical recurrence risk criteria (ISUP Grade Group ≤2, PSA doubling time more than 12 months), with no definite/probable recurrent prostate cancer on PSMA-PET/CT.This article is protected by copyright. All rights reserved.