101. PCA3 as a second-line biomarker in a prospective controlled randomized opportunistic prostate cancer screening programme
- Author
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Antonio Fernandez-Serra, Álvaro Gómez-Ferrer, M. Vanaclocha, José Rubio-Briones, A. Collado, D. Sala, F. Martínez, A. Molina, R. Dumont, M. Ramírez-Backhaus, José Antonio López-Guerrero, J. Domínguez-Escrig, L. Rubio, and Juan Casanova
- Subjects
Adult ,Male ,PCA3 ,medicine.medical_specialty ,030232 urology & nephrology ,Urology ,urologic and male genital diseases ,law.invention ,Opportunistic screening ,03 medical and health sciences ,Prostate cancer ,PSA ,0302 clinical medicine ,Second line ,Randomized controlled trial ,Antigens, Neoplasm ,law ,Biopsy ,Biomarkers, Tumor ,medicine ,Humans ,Prospective Studies ,Early Detection of Cancer ,Aged ,Gynecology ,medicine.diagnostic_test ,business.industry ,Prostatic Neoplasms ,General Medicine ,Rectal examination ,Middle Aged ,medicine.disease ,Prostate cancer screening ,030220 oncology & carcinogenesis ,Biomarker (medicine) ,business - Abstract
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= 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.
- Published
- 2017