title: Short-term outcomes of the prospective multicentre 'Prostate Cancer Research International: Active Surveillance' study.
abstract: OBJECTIVE
  To evaluate the short-term outcomes of the prospective international Prostate Cancer Research International: Active Surveillance ('PRIAS') study (Dutch Trial Register NTR1718), as active surveillance (AS) for early prostate cancer might provide a partial solution to the current overtreatment dilemma in this disease.
  
  
  METHODS
  The first 500 (of >950) participants with asymptomatic T1c/T2 prostate cancer, with a prostate-specific antigen (PSA) level of < or =10.0 ng/mL, a PSA density of <0.2 ng/mL/mL, a Gleason score of < or =3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow-up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1-year repeat biopsies, and outcomes after radical prostatectomy (RP).
  
  
  RESULTS
  Patients were included between December 2006 and July 2008. The median (25-75th percentile) follow-up after diagnosis was 1.02 (0.6-1.5) years. The 2-year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow-up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score of >6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0-10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re-biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of >6.
  
  
  CONCLUSIONS
  AS seems feasible, but mortality outcomes are unknown. A strict follow-up protocol including standard 1-year repeat biopsies resulted in a quarter of men stopping AS after 2 years.
authors.affiliation: Department of Urology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands. r.vandenbergh@erasmusmc.nl
authors.forename: Roderick C N
authors.initials: RC
authors.lastname: van den Bergh
authors.forename: Hanna
authors.initials: H
authors.lastname: Vasarainen
authors.forename: Henk G
authors.initials: HG
authors.lastname: van der Poel
authors.forename: Jenneke J
authors.initials: JJ
authors.lastname: Vis-Maters
authors.forename: John B
authors.initials: JB
authors.lastname: Rietbergen
authors.forename: Tom
authors.initials: T
authors.lastname: Pickles
authors.forename: Erik B
authors.initials: EB
authors.lastname: Cornel
authors.forename: Riccardo
authors.initials: R
authors.lastname: Valdagni
authors.forename: Joris J
authors.initials: JJ
authors.lastname: Jaspars
authors.forename: John
authors.initials: J
authors.lastname: van der Hoeven
authors.forename: Frederic
authors.initials: F
authors.lastname: Staerman
authors.forename: Eric H G M
authors.initials: EH
authors.lastname: Oomens
authors.forename: Antti
authors.initials: A
authors.lastname: Rannikko
authors.forename: Stijn
authors.initials: S
authors.lastname: Roemeling
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: Monique J
authors.initials: MJ
authors.lastname: Roobol
authors.forename: Fritz H
authors.initials: FH
authors.lastname: Schröder
authors.forename: Chris H
authors.initials: CH
authors.lastname: Bangma
mesh_terms: D000368:Aged; D001707:Biopsy, Needle; D002170:Canada / Q000453:epidemiology; D004812:Epidemiologic Methods; D005060:Europe / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance / Q000379:methods; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D017430:Prostate-Specific Antigen