PCA3 as a second-line biomarker in a prospective controlled randomized opportunistic prostate cancer screening programme


Por: Rubio-Briones J, Casanova J, Martínez F, Domínguez-Escrig JL, Fernández-Serra A, Dumont R, Ramírez-Backhaus M, Gómez-Ferrer A, Collado A, Rubio L, Molina A, Vanaclocha M, Sala D and Lopez-Guerrero JA

Publicada: 1 jun 2017
Categoría: Urology

Resumen:
Objectives: 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). Material and methods: 5,199 men, aged 40-75y, underwent prostate-specific antigen (PSA) screening and digital rectal examination (DRE). Men with a normal DRE and PSA >= 3 ng/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. Results: 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. Conclusions: When PCA3-35 is used as a second-line biomarker when PSA >= 3 ng/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. (C) 2016 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.
ISSN: 02104806





ACTAS UROLOGICAS ESPANOLAS
Editorial
ENE EDICIONES SL, REDACCION, ADMINISTRACION & PUBLICIDAD, ORURO 9 - BAJO IZDA, MADRID, 28016, SPAIN, Reino Unido
Tipo de documento: Article
Volumen: 41 Número: 5
Páginas: 300-308
WOS Id: 000403132200004
ID de PubMed: 28342633

MÉTRICAS