Rubio-Briones J, Casanova J, Martínez F, Domínguez-Escrig J L, Fernández-Serra A, Dumont R, Ramírez-Backhaus M, Gómez-Ferrer A, Collado A, Rubio L, Molina A, Vanaclocha M, Sala D, Lopez-Guerrero J A
Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
Actas Urol Esp. 2017 Jun;41(5):300-308. doi: 10.1016/j.acuro.2016.10.008. Epub 2017 Mar 23.
PCA3 performance as a single second line biomarker is compared to the European Randomised Study of Screening for Prostate Cancer risk calculator model 3 (ERSPC RC-3) in an opportunistic screening in prostate cancer (PCa).
5,199 men, aged 40-75y, underwent prostate-specific antigen (PSA) screening and digital rectal examination (DRE). Men with a normal DRE and PSA ≥3ng/ml had a PCA3 test done. All men with PCA3 ≥35 underwent an initial biopsy (IBx) -12 cores-. Men with PCA3 <35 were randomized 1:1 to either IBx or observation. We compared them to those obtained with ERSPC RC-3.
PCA3 test was performed on 838 men (16.1%). In PCA3(+) and PCA3(-) groups, global PCa detection rates were 40.9% and 14.7% with a median follow-up (FU) of 21.7 months (P<.001). In the PCA3(+) arm (n=301, 35.9%), PCa was identified in 115 men at IBx (38.2%). In the randomized arm, 256 underwent IBx and PCa was found in 46 (18.0%) (P<.001). The biopsy-sparing potential would have been 64.1% as opposed to 76.6% if we had used ERSPC RC-3. However, the estimated false negative cases for HGPCa would have been reduced by 37.1% (89 to 56 patients). Moreover, if we had applied PCA3-35 to avoid IBx, 14.7% PCa and 9.1% of clinical significant PCa patients would not have been diagnosed during this FU.
When PCA3-35 is used as a second-line biomarker when PSA ≥3ng/ml and DRE is normal, IBx could be avoided in 12.5% less than if ERSPC RC-3 is used and would reduce the false negative cases by 36.2%. At a FU of 21.7 months, this dual protocol would miss 9.1% of clinically significant PCa, so strict FU is mandatory with established biopsy criteria based on PSA and DRE in cases with PCA3 <35.
在前列腺癌（PCa）的机会性筛查中，将PCA3作为单一二线生物标志物的性能与欧洲前列腺癌筛查随机研究风险计算器模型3（ERSPC RC - 3）进行比较。
5199名年龄在40 - 75岁的男性接受了前列腺特异性抗原（PSA）筛查和直肠指检（DRE）。DRE正常且PSA≥3ng/ml的男性进行了PCA3检测。所有PCA3≥35的男性接受了初次活检（IBx）——12针活检。PCA3<35的男性按1:1随机分为IBx组或观察组。我们将他们与使用ERSPC RC - 3获得的数据进行比较。
对838名男性（16.1%）进行了PCA3检测。在PCA3阳性和PCA3阴性组中，总体PCa检出率分别为40.9%和14.7%，中位随访（FU）时间为21.7个月（P<0.001）。在PCA3阳性组（n = 301，35.9%）中，115名男性（38.2%）在IBx时被确诊为PCa。在随机分组组中，256名男性接受了IBx，其中46名（18.0%）被发现患有PCa（P<0.001）。与使用ERSPC RC - 3相比，活检保留潜力为64.1%，而使用ERSPC RC - 3时为76.6%。然而，高级别PCa的估计假阴性病例将减少37.1%（从89例降至56例）。此外，如果我们应用PCA3 - 35来避免IBx，在本次随访期间，14.7%的PCa患者和9.1%的具有临床意义的PCa患者将无法被诊断出来。
当PSA≥3ng/ml且DRE正常时，将PCA3 - 35用作二线生物标志物，与使用ERSPC RC - 3相比，可减少12.5%的IBx，且假阴性病例减少36.2%。在21.7个月的随访中，这种双重方案会漏诊9.1%的具有临床意义的PCa，因此对于PCA3<35的病例，基于PSA和DRE建立活检标准并进行严格随访是必要的。
