有组织的前列腺癌筛查计划:意大利泌尿学会 (SIU) 的提议。
Organized prostate cancer screening program: a proposal from the Italian Society of Urology (SIU).
发表日期:2024 Oct
作者:
Vincenzo Ficarra, Riccardo Bartoletti, Marco Borghesi, Orazio Caffo, Cosimo DE Nunzio, Ugo G Falagario, Giorgio Gandaglia, Gianluca Giannarini, Andrea Minervini, Vincenzo Mirone, Francesco Porpiglia, Bernardo Rocco, Andrea Salonia, Paolo Verze, Giuseppe Carrieri,
来源:
Minerva Urology and Nephrology
摘要:
为了对比机会性 PCa 筛查,欧盟理事会建议将筛查计划扩展到 PCa,建议在欧盟国家实施逐步方法,以评估基于 PSA 测试并结合额外 MRI 的有组织计划的可行性和有效性,如下:向上测试。这份基于专家的文件的目的是根据欧盟理事会的建议提出有组织的前列腺癌筛查计划。意大利泌尿外科学会 (SIU) 组建了一个专家小组,旨在报告 1) 有关 PCa 发病率、患病率和死亡率的最新流行病学数据; 2) 最重要的风险因素,用于识别最终罹患该疾病的风险增加的男性类别; 3) 最相关的研究提供基于人群的筛查数据; 4) 主要国际指南的当前建议。根据之前的证据,专家小组提出了一些建议,为预期寿命至少为 15 年的无症状男性制定新的有组织的 PCa 筛查计划。 SIU 小组强烈支持实施一项有组织的试点 PCa 筛查计划,邀请年龄在 50-55 岁之间的无症状男性。已经进行机会性筛查的受邀男性将被随机分配以继续机会性筛查或进入有组织的方案。 PSA 水平≤3 ng/mL 且熟悉前列腺癌的男性以及所有 PSA 水平> 3 ng/mL 的男性均接受了 DRE。所有其他 PSA 水平大于 3 ng/mL 的男性均继续进行以 mpMRI 为代表的二次测试。患有前列腺成像报告和数据系统 (PI-RADS) 病变 3 且 PSAD 0.15 ng/mL/cc 或更高的男性以及患有 PI-RADS 4-5 病变的男性继续进行靶向加系统前列腺活检。拟议的 PCa 筛查试点计划的主要结果将是具有临床意义的 PCa 的检出率,该 PCa 被定义为 ISUP 分级组≥2 的肿瘤。主要次要结局是侵袭性 PCa 的检出率(ISUP 等级组≥4);微不足道的 PCa 检出率(ISUP 1 级);避免不必要的前列腺活检次数、无转移生存率和总生存率。男性将被邀请为期一年。初步分析将计划在基线入组后 2 年和 5 年进行。根据欧盟理事会最近关于癌症筛查的建议,在选定的患者群体中,评估 PCa 筛查项目的可行性和有效性的试点研究必须得到科学协会的大力推动和国家的支持,其中 PSA 作为主要筛查方法,mpMRI 作为次要筛查测试。各国政府。
To contrast opportunistic PCa screening, the European Union Council suggested extending screening programs to PCa by recommending the implementation of a stepwise approach in the EU Countries to evaluate the feasibility and effectiveness of an organized program based on PSA testing in combination with additional MRI as a follow-up test. The objective of this expert-based document is to propose an organized PCa screening program according to the EU Council recommendations. The Italian Society of Urology (SIU) developed a team of experts with the aim to report 1) the most recent epidemiologic data about incidence, prevalence, and mortality of PCa; 2) the most important risk factors to identify categories of men with an increased risk to eventually develop the disease; 3) the most relevant studies presenting data on population-based screening; and 4) the current recommendations of the leading International Guidelines. According to previous evidence, the Panel proposed some indications to develop a new organized PCa screening program for asymptomatic men with a life-expectancy of at least fifteen years. The SIU Panel strongly supports the implementation of a pilot, organized PCa screening program inviting asymptomatic men in the age range of 50-55 years. Invited men who are already performing opportunistic screening will be randomized to continue opportunistic screening or to cross into the organized protocol. Men with PSA level ≤3 ng/mL and familiarity for PCa received a DRE as well as all those with PSA levels >3 ng/mL. All other men with PSA levels greater than 3 ng/mL proceed to secondary testing represented by mpMRI. Men with Prostate Imaging-Reporting and Data System (PI-RADS) lesions 3 and PSAD 0.15 ng/mL/cc or higher as well as those with PI-RADS 4-5 lesions proceed to targeted plus systematic prostate biopsy. The primary outcome of the proposed pilot PCa screening program will be the detection rate of clinically significant PCa defined as a tumor with a ISUP Grade Group ≥2. Main secondary outcomes will be the detection rate of aggressive PCa (ISUP Grade Group ≥4); the detection rate of insignificant PCa (ISUP Grade Group 1); the number of unnecessary prostate biopsy avoided, the metastasis-free survival, and the overall survival. Men will be invited over a one-year period. Preliminary analyses will be planned 2 and 5 years after the baseline enrollment. According to the recent EU Council recommendations on cancer screening, pilot studies evaluating the feasibility and effectiveness of PCa screening programs using PSA as the primary and mpMRI as the secondary screening test in selected cohorts of patients must be strongly promoted by scientific societies and supported by national governments.