Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Division of Cancer Treatment and Diagnosis: Biometric Research Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland.
J Urol. 2016 Sep;196(3):690-6. doi: 10.1016/j.juro.2016.04.057. Epub 2016 Apr 18.
Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) was developed to standardize the interpretation and reporting of multiparametric prostate magnetic resonance imaging and provide guidelines for biopsy of multiparametric magnetic resonance imaging findings. We prospectively evaluated the cancer detection rate at each overall PI-RADSv2 score.
This prospective study included 62 consecutive patients with 116 lesions who underwent multiparametric prostate magnetic resonance imaging at 3T with PI-RADSv2 evaluation and subsequent targeted magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and concurrent 12-core systematic prostate biopsy between May and September 2015. Median patient age and prostate specific antigen values were 65.5 years (range 50.3 to 76.6) and 7.10 ng/ml (range 0.47 to 863.0), respectively. Mean lesion size was 12.7 mm overall. Lesion based cancer detection rates for all tumors and for Gleason 3+4 or greater tumors at each PI-RADSv2 score were calculated. Univariate analysis was performed to assess differences in the cancer detection rate among PI-RADSv2 scores.
A total of 116 lesions in 62 patients were evaluated prospectively (0 PI-RADS 1, 18 PI-RADS 2, 19 PI-RADS 3, 47 PI-RADS 4, 32 PI-RADS 5), and the patients underwent magnetic resonance/transrectal ultrasound fusion guided biopsy and systematic biopsy. Histopathology revealed 55 of 116 (47.4%) cancers (17 Gleason 3+3, 16 Gleason 3+4, 6 Gleason 4+3, 12 Gleason 4+4, 3 Gleason 4+5 and 1 Gleason 5+4). Based on targeted biopsy on a per lesion basis, the overall cancer detection rates of PI-RADS 2, 3, 4 and 5 scores for all tumors was 22.2%, 15.8%, 29.8% and 78.1%, respectively. The cancer detection rate of PI-RADS 2, 3, 4 and 5 scores for Gleason 3+4 or greater tumors was 5.6%, 0%, 21.3% and 75%, respectively. Differences in the cancer detection rate between overall PI-RADS 4 and 5 scores were significant (p <0.001 for Gleason greater than 3+3 and Gleason 3+4 or greater cancers).
A PI-RADS score of 5 had the highest prospective cancer detection rate (78%). A PI-RADS score of 4 had only a 30% cancer detection rate, which is lower than expected. Surprisingly, no or few significant cancers were detected at a PI-RADS score of 3 (16%). These early prospective data suggest that current criteria result in a high false-positive rate that lowers the cancer detection rate. Therefore, stricter criteria may be needed in the future to decrease false-positives and increase the cancer detection rate for PI-RADS scores of 3, 4 and 5.
前列腺影像报告和数据系统第 2 版（PI-RADSv2）旨在规范多参数前列腺磁共振成像的解释和报告，并为多参数磁共振成像结果的活检提供指南。我们前瞻性地评估了每个总体 PI-RADSv2 评分的癌症检出率。
这项前瞻性研究包括 2015 年 5 月至 9 月期间在 3T 上进行多参数前列腺磁共振成像并进行 PI-RADSv2 评估以及随后进行靶向磁共振成像/经直肠超声融合引导活检和同期进行 12 芯系统前列腺活检的 62 例连续患者，共 116 个病灶。中位患者年龄和前列腺特异性抗原值分别为 65.5 岁（范围 50.3 至 76.6）和 7.10ng/ml（范围 0.47 至 863.0）。平均病灶大小为 12.7mm。计算了所有肿瘤和 PI-RADSv2 评分下 Gleason 3+4 或更高肿瘤的基于病灶的癌症检出率。进行了单变量分析以评估 PI-RADSv2 评分之间癌症检出率的差异。
前瞻性评估了 62 例患者的 116 个病灶（0 PI-RADS 1，18 PI-RADS 2，19 PI-RADS 3，47 PI-RADS 4，32 PI-RADS 5），并进行了磁共振/经直肠超声融合引导活检和系统活检。组织病理学显示 116 个病灶中的 55 个（17 个 Gleason 3+3，16 个 Gleason 3+4，6 个 Gleason 4+3，12 个 Gleason 4+4，3 个 Gleason 4+5 和 1 个 Gleason 5+4）。基于靶向活检，PI-RADS 2、3、4 和 5 评分的所有肿瘤的总体癌症检出率分别为 22.2%、15.8%、29.8%和 78.1%。PI-RADS 2、3、4 和 5 评分的 Gleason 3+4 或更高肿瘤的癌症检出率分别为 5.6%、0%、21.3%和 75%。PI-RADS 4 和 5 评分之间的癌症检出率差异具有统计学意义（Gleason 大于 3+3 和 Gleason 3+4 或更高癌症的 p<0.001）。
PI-RADS 评分 5 具有最高的前瞻性癌症检出率（78%）。PI-RADS 评分 4 的癌症检出率仅为 30%，低于预期。令人惊讶的是，PI-RADS 评分 3 几乎没有或没有显著的癌症（16%）。这些早期前瞻性数据表明，目前的标准导致高假阳性率，降低了癌症检出率。因此，未来可能需要更严格的标准来降低 PI-RADS 评分 3、4 和 5 的假阳性率并提高癌症检出率。
