Multi-cohort effectiveness of Gallium-68-PSMA PET/CT and pelvic 3Tesla multi-parametric magnetic resonance imaging in the diagnostic and therapeutic work-up of prostate cancer (MoH RF-2016-02364230)

The project "Multi-cohort effectiveness of Gallium-68-PSMA PET/CT and pelvic 3Tesla multi-parametric magnetic resonance imaging in the diagnostic and therapeutic work-up of prostate cancer" is funded by Italian Ministry of Health (project code: RF-2016-02364230) Based on preliminary data, the project hypothesis was that diagnostic accuracy of 68Ga-PSMA PET/CT is comparable to that of mp-3TMRI in pts with pCa. If that is the case, the use of 68Ga-PSMA PET/CT will lead to shorter waiting lists, faster scanning time and lower costs compared to mp-3TMRI. The 1st goal of this project is to guide or replace invasive procedures with a non invasive approach such as mp-3TMRI or 68Ga-PSMA PET/CT. The secondary aim is a comparative analysis of the 2 techniques. Specific Aim 1: Characterize the incremental benefit of pelvic mp-MRI and 68Ga-PSMA PET/CT in: guiding TRUS-B, to identify clinicallysignificant PCa in pts who are negative at first-round TRUS-B and/or are undergoing AS. Stage accuracy of pelvic mp-MRI and 68Ga PSMA PET/CT during the pre-surgical work-up of high-risk PCa pts and PCa pts who are candidates for nerve-sparing surgery. The secondary aim is a comparative analysis of the 2 techniques. Specific Aim 2: Evaluate the accurancy of 68Ga-PSMA PET/CT (i.e. Sensitivity, SE; specificity, SP) in detecting sites of biochemical PCa recurrence compared to routinely-used diagnostic tools (TRUS-B, bone scan, diagnostic CT, MRI and 18F-FCH PET/CT). The secondary objectives are SE for different PSA values and SE for different Gleason score. Specific Aim 3: Evaluate the efficacy in terms of Disease Control Rate (DCR) and the safety of 2 different administration schedules of 177Lu-PSMA in a cohort (C) of metastatic CRPC pts previously treated with standard therapy.《镓-68-PSMA PET/CT与盆腔3特斯拉多参数磁共振成像在前列腺癌诊疗流程中的多队列有效性研究》项目由意大利卫生部资助（项目编号：RF-2016-02364230）。 基于初步研究数据，本项目提出如下假说：前列腺癌（prostate cancer, pCa）患者中，68Ga-PSMA PET/CT的诊断准确性可与mp-3TMRI相媲美。若该假说成立，相较于mp-3TMRI，68Ga-PSMA PET/CT的应用可缩短等待时长、加快扫描流程并降低诊疗成本。本项目的首要目标是采用mp-3TMRI或68Ga-PSMA PET/CT这类非侵入性手段，指导或替代侵入性操作；次要目标为对这两种技术开展对比分析。 具体目标1： 明确盆腔mp-MRI与68Ga-PSMA PET/CT的增量获益，具体包括：①指导经直肠超声引导下前列腺穿刺活检（Transrectal Ultrasound-guided Biopsy, TRUS-B），以识别首轮经直肠超声引导下前列腺穿刺活检结果呈阴性、或正在接受主动监测（Active Surveillance, AS）的患者中存在临床意义的前列腺癌；②在高危前列腺癌患者以及拟行保留神经手术的前列腺癌患者的术前评估中，明确盆腔mp-MRI与68Ga-PSMA PET/CT的分期准确性。本部分次要目标仍为对两种技术开展对比分析。 具体目标2： 相较于临床常规使用的诊断工具（经直肠超声引导下前列腺穿刺活检、骨扫描、诊断性CT、MRI以及18F-FCH PET/CT），评估68Ga-PSMA PET/CT检测前列腺癌生化复发病灶的准确性（即灵敏度（Sensitivity, SE）、特异度（Specificity, SP））。次要目标为分析不同前列腺特异性抗原（Prostate Specific Antigen, PSA）水平下的灵敏度，以及不同格里森评分（Gleason Score）下的灵敏度。 具体目标3： 在既往接受过标准治疗的转移性去势抵抗性前列腺癌（metastatic Castration-resistant Prostate Cancer, mCRPC）患者队列（C）中，评估177Lu-PSMA两种不同给药方案的疾病控制率（Disease Control Rate, DCR）疗效与安全性。