Department of Radiological Sciences, Oncology and Pathology, Sapienza University/Policlinico Umberto I, Viale del Policlinico 155, 00185, Rome, Italy.
Department of Public Health and Infectious Diseases, Sapienza University/Policlinico Umberto I, Viale del Policlinico 155, 00185, Rome, Italy.
Eur Radiol. 2024 Jan;34(1):204-213. doi: 10.1007/s00330-023-10019-1. Epub 2023 Aug 10.
The main objective is to propose an MRI-based screening protocol, investigating the role of MRI without the injection of contrast media (bi-parametric MRI, bpMRI) as a secondary prevention test for prostate cancer (PCa) early diagnosis, comparing MRI with the prostate specific antigen (PSA) test. For this reason, preliminary results of Prostate Cancer Secondary Screening in Sapienza (PROSA) are presented, to investigate the efficiency of an MRI-based screening protocol. PROSA is a prospective, randomized, single-center study. To date, 351 men have been enrolled and blindly randomized into two different arms: (A) Men underwent a bpMRI regardless of their PSA values (175); (B) Men followed as per clinical practice: those with increased PSA (61) were referred to bpMRI, while those with normal PSA (112) were not. Men who screened positive on MRI were directed to MR-directed targeted biopsy. On arm A, 4 clinically significant PCa have been detected, while none was found on arm B (p = 0.046). To evaluate the efficiency of the screening protocol, we calculated the experimental event rate (EER, 3.6%), control event rate (CER, 1.2%.), absolute risk reduction (ARR, 2.5%), and number needed to treat (NNT, 40.3). PROSA represents an interesting experience in the field of imaging-based PCa screening. The preliminary data from this trial highlight the promising role of non-contrast MRI as a screening tool for early detection of PCa. Further data will finally validate the most appropriate screening program.
PROSA depicts an interesting experience in the field of research focused on imaging-based prostate cancer screening. Its preliminary data highlight the promising role of non-contrast MRI as a screening tool for early detection of PCa.
• Promotion of an MRI-based screening protocol, investigating the role of non-contrast MRI as a secondary prevention test for prostate cancer early diagnosis, comparing MRI with PSA test. • Prostate Cancer Secondary Screening in Sapienza (PROSA) represents an interesting experience in the field of research focused on imaging-based prostate cancer screening; its preliminary results indicate that it is possible to use non-contrast MRI as a screening tool for early detection of PCa. • This new approach to PCa screening could facilitate the early diagnosis of clinically significant prostate cancer while reducing the number of unnecessary prostate biopsies and the detection of clinically insignificant prostate cancer.
本研究旨在提出一种基于 MRI 的筛查方案，探讨不注射造影剂的 MRI（双参数 MRI，bpMRI）作为前列腺癌（PCa）早期诊断的二级预防检测的作用，将 MRI 与前列腺特异性抗原（PSA）检测进行比较。为此，介绍了 Prostate Cancer Secondary Screening in Sapienza（PROSA）的初步结果，以研究基于 MRI 的筛查方案的效率。PROSA 是一项前瞻性、随机、单中心研究。迄今为止，已有 351 名男性入组并进行了盲法随机分组：（A）无论 PSA 值如何，患者均接受 bpMRI（175 名）；（B）按照临床实践进行随访：PSA 升高（61 名）的患者转至 bpMRI，PSA 正常（112 名）的患者不进行检查。MRI 筛查阳性的患者接受 MRI 靶向活检。在 A 组中，检测到 4 例临床显著的 PCa，而 B 组未发现（p=0.046）。为了评估筛查方案的效率，我们计算了实验事件率（EER，3.6%）、对照事件率（CER，1.2%）、绝对风险降低（ARR，2.5%）和需要治疗的人数（NNT，40.3）。PROSA 代表了在基于影像学的 PCa 筛查领域的一次有趣尝试。该试验的初步数据突出了非对比 MRI 作为早期发现 PCa 的筛查工具的有前景的作用。进一步的数据将最终验证最合适的筛查方案。
PROSA 描绘了在基于影像学的前列腺癌筛查领域的一项有趣尝试。其初步数据突出了非对比 MRI 作为早期发现 PCa 的筛查工具的有前景的作用。
• 推广基于 MRI 的筛查方案，探讨非对比 MRI 在前列腺癌早期诊断中的二级预防检测作用，将 MRI 与 PSA 检测进行比较。
• Prostate Cancer Secondary Screening in Sapienza（PROSA）是一项在基于影像学的前列腺癌筛查领域进行的有趣研究，其初步结果表明，可以使用非对比 MRI 作为早期发现 PCa 的筛查工具。
• 这种新的前列腺癌筛查方法可以促进临床显著前列腺癌的早期诊断，同时减少不必要的前列腺活检数量和发现临床意义不大的前列腺癌。
