title: Optimizing prostate cancer screening; prospective randomized controlled study of the role of PSA and PCA3 testing in a sequential manner in an opportunistic screening program.
abstract: OBJECTIVE
  To reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer.
  
  
  METHODS
  We perform a prospective evaluation of PCA3 as a second line biomarker in an opportunistic screening for prostate cancer (PCa). From September-2010 until September-2012, 2,366 men, aged 40-74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA >3 ng/ml were submitted for PCA3. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) -12cores-. Men with PCA3 < 35 were randomized 1:1 to either IBx or observation. Re-biopsy(16-18 cores) criteria were PSA increase >.5 ng/ml at 4-6 months or PSAv > .75 ng/ml/year.
  
  
  RESULTS
  With median follow-up (FU) of 10.1 months, PCA3 was performed in 321/2366 men (13.57%), 289 at first visit and 32 during FU. All 110 PCA3+ men (34.3%) were biopsied and PCa was identified in 43 men in IBx (39.1%). In the randomized arm, 110 were observed and 101 underwent biopsy, finding 12 PCa (11.9%), showing a statistically significant reduction of PCa detection rate in this cohort (P<.001). Global PCa detection rates were 40.9% and 9.5% for the PCA3+ and PCA3- branches, respectively (P<.001). Area under the curve for PSA and PCA3 were .601 and .74, respectively. This is an ongoing prospective study limited by its short follow-up period and still limited enrolment.
  
  
  CONCLUSIONS
  PCA3 as a second line biomarker within an opportunistic dual screening protocol, can potentially avoid 65.7% and 50.1% biopsies at first round and at median FU of 10.1 months, respectively, just missing around 3.2% of high grade PCa.
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España. Electronic address: jrubio@fivo.org.
authors.forename: J
authors.initials: J
authors.lastname: Rubio-Briones
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: J
authors.initials: J
authors.lastname: Casanova
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: R
authors.initials: R
authors.lastname: Dumont
authors.affiliation: Laboratorio de Biología Molecular, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: L
authors.initials: L
authors.lastname: Rubio
authors.affiliation: Laboratorio de Biología Molecular, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: A
authors.initials: A
authors.lastname: Fernandez-Serra
authors.affiliation: Laboratorio de Biología Molecular, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: I
authors.initials: I
authors.lastname: Casanova-Salas
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: J
authors.initials: J
authors.lastname: Domínguez-Escrig
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: M
authors.initials: M
authors.lastname: Ramírez-Backhaus
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: A
authors.initials: A
authors.lastname: Collado
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: A
authors.initials: A
authors.lastname: Gómez-Ferrer
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: I
authors.initials: I
authors.lastname: Iborra
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: J L
authors.initials: JL
authors.lastname: Monrós
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: J V
authors.initials: JV
authors.lastname: Ricós
authors.affiliation: Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: E
authors.initials: E
authors.lastname: Solsona
authors.affiliation: Departamento de Salud Pública, Consellería de Sanidad, Generalitat Valenciana, Valencia, España.
authors.forename: D
authors.initials: D
authors.lastname: Salas
authors.affiliation: Departamento de Bioestadística, Universidad de Valencia, Valencia, España.
authors.forename: F
authors.initials: F
authors.lastname: Martínez
authors.affiliation: Laboratorio de Biología Molecular, Fundación Instituto Valenciano de Oncología, Valencia, España.
authors.forename: J A
authors.initials: JA
authors.lastname: Lopez-Guerrero
mesh_terms: D000951:Antigens, Neoplasm / Q000097:blood*; D014408:Biomarkers, Tumor / Q000097:blood*; D001706:Biopsy; D055088:Early Detection of Cancer; D006801:Humans; D008297:Male; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis*
chemical_list: D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; C479341:prostate cancer antigen 3, human; D017430:Prostate-Specific Antigen
keywords: Biopsia prostática; Cribado; Cáncer de próstata; PCA3; Prostate biopsy; Prostate cancer; Screening