Department of Urology, 16810Vall d´Hebron Hospital, Barcelona, Spain.
Prostate Cancer Research Group, Vall d´Hebron Research Institute, Barcelona, Spain.
Int J Biol Markers. 2022 Jun;37(2):218-223. doi: 10.1177/03936155221081537. Epub 2022 Feb 24.
Proclarix is a new blood-based test to assess the likelihood of clinically significant prostate cancer (csPCa) defined as 2 grade group. In this study, we analyzed whether Proclarix and PSA density (PSAD) could improve the selection of candidates for prostate biopsy after multiparametric magnetic resonance imaging (mpMRI). Proclarix and PSAD were assessed in 567 consecutive men with suspected PCa in whom pre-biopsy 3 Tesla mpMRI, scoring with Prostate Imaging-Report and Data System (PI-RADS) v.2, and guided and/or systematic biopsies were performed. Proclarix and PSAD thresholds having csPCa sensitivity over 90% were found at 10% and 0.07 ng/(mL*cm), respectively. Among 100 men with negative mpMRI (PI-RADS <3), csPCa was detected in 6 cases, which would have been undetected if systematic biopsies were avoided. However, Proclarix suggested performing a biopsy on 70% of men with negative mpMRI. In contrast, PSAD only detected 50% of csPCa and required 71% of prostate biopsies. In 169 men with PI-RADS 3, Proclarix avoided 21.3% of prostate biopsies and detected all 25 cases of csPCa, while PSAD avoided 26.3% of biopsies, but missed 16% of csPCa. In 190 men with PI-RADS 4 and 108 with PI-RADS 5, Proclarix avoided 12.1% and 5.6% of prostate biopsies, but missed 4.8% and 1% of csPCa, respectively. PSAD avoided 18.4% and 9.3% of biopsies, but missed 11.4% and 4.2% csPCa, respectively. We conclude that Proclarix outperformed PSAD in the selection of candidates for prostate biopsy, especially in men with PI-RADS 3.
Proclarix 是一种新的基于血液的检测方法,用于评估临床显著前列腺癌(csPCa)的可能性,定义为 2 级分组。在这项研究中,我们分析了 Proclarix 和 PSA 密度(PSAD)是否可以改善多参数磁共振成像(mpMRI)后前列腺活检的候选者选择。在接受前列腺癌可疑的 567 例连续男性中评估了 Proclarix 和 PSAD,这些患者在活检前进行了 3T 磁共振成像,评分采用前列腺成像报告和数据系统(PI-RADS)v.2,并进行了靶向和/或系统活检。发现 Proclarix 和 PSAD 的阈值分别为 10%和 0.07ng/(mL*cm),具有超过 90%的 csPCa 敏感性。在 100 例 mpMRI 阴性(PI-RADS<3)的男性中,检测到 6 例 csPCa,如果避免系统活检,这些病例将无法检测到。然而,Proclarix 建议对 70%的 mpMRI 阴性男性进行活检。相比之下,PSAD 仅检测到 50%的 csPCa,需要进行 71%的前列腺活检。在 169 例 PI-RADS 3 的男性中,Proclarix 避免了 21.3%的前列腺活检,并检测到所有 25 例 csPCa,而 PSAD 避免了 26.3%的活检,但漏诊了 16%的 csPCa。在 190 例 PI-RADS 4 和 108 例 PI-RADS 5 的男性中,Proclarix 分别避免了 12.1%和 5.6%的前列腺活检,但分别漏诊了 4.8%和 1%的 csPCa,PSAD 分别避免了 18.4%和 9.3%的活检,但分别漏诊了 11.4%和 4.2%的 csPCa。我们得出结论,Proclarix 在前列腺活检候选者的选择方面优于 PSAD,尤其是在 PI-RADS 3 的男性中。