The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), Camperdown, NSW, Australia.
Royal Brisbane and Women's Hospital, Herston, Qld, Australia.
BJU Int. 2024 Feb;133 Suppl 3:39-47. doi: 10.1111/bju.16158. Epub 2023 Sep 14.
Salvage radiation therapy (SRT) and surveillance for low-risk prostate-specific antigen (PSA) recurrence have competing risks and benefits. The efficacy of early SRT to the prostate bed with or without pelvic lymph nodes compared to surveillance in patients with PSA recurrence after radical prostatectomy and no identifiable recurrent disease evident on prostate specific membrane antigen-positron emission tomography/computer tomography (PSMA-PET/CT) is unknown.
The Dedicated Imaging Post-Prostatectomy for Enhanced Radiotherapy outcomes (DIPPER) is an open-label, multicentre, randomised Phase II trial.
The primary endpoint is 3-year event-free survival, with events comprising one of PSA recurrence (PSA ≥0.2 ng/mL higher than baseline), radiological 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 after radical prostatectomy, defined by serum PSA level of 0.2-0.5 ng/mL, deemed low risk according to modified European Association of Urology biochemical recurrence risk criteria (International Society for Urological Pathology Grade Group ≤2, PSA doubling time >12 months), with no definite/probable recurrent prostate cancer on PSMA-PET/CT.
A total of 100 participants will be recruited from five Australian centres and randomised 1:1 to SRT or surveillance. Participants will undergo 6-monthly clinical evaluation for up to 36 months. Androgen-deprivation therapy is not permissible. Enrolment commenced May 2023.
This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622001478707).
挽救性放疗（SRT）和低危前列腺特异性抗原（PSA）复发的监测存在竞争风险和获益。根治性前列腺切除术后 PSA 复发且前列腺特异性膜抗原阳性正电子发射断层扫描/计算机断层扫描（PSMA-PET/CT）未见明确复发病灶的患者，早期行前列腺床 SRT 联合或不联合盆腔淋巴结清扫与监测相比的疗效尚不清楚。
专门用于增强放疗结果的前列腺切除术后影像学检查（DIPPER）是一项开放标签、多中心、随机 2 期试验。
主要终点为 3 年无事件生存率，事件包括 PSA 复发（PSA 较基线升高≥0.2ng/ml）、远处转移的影像学证据或开始全身或其他挽救性治疗。次要终点包括患者报告结局、治疗模式、参与者认知和成本效益。
符合条件的参与者为根治性前列腺切除术后 PSA 复发的前列腺癌患者，定义为血清 PSA 水平为 0.2-0.5ng/ml，根据改良的欧洲泌尿外科学会生化复发风险标准（国际泌尿病理学会分级组≤2，PSA 倍增时间>12 个月），PSMA-PET/CT 未见明确/可能的复发性前列腺癌。
将从 5 个澳大利亚中心招募 100 名参与者，并以 1:1 的比例随机分配至 SRT 或监测组。参与者将接受 6 个月的临床评估，最长 36 个月。不允许使用雄激素剥夺疗法。该试验于 2023 年 5 月开始入组。
该试验已在澳大利亚和新西兰临床试验注册中心（ACTRN：ACTRN12622001478707）注册。
