PMID- 23176897
OWN - NLM
STAT- MEDLINE
DCOM- 20130924
LR  - 20211122
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 63
IP  - 5
DP  - 2013 May
TI  - Dutasteride treatment over 2 years delays prostate-specific antigen progression 
      in patients with biochemical failure after radical therapy for prostate cancer: 
      results from the randomised, placebo-controlled Avodart After Radical Therapy for 
      Prostate Cancer Study (ARTS).
PG  - 779-87
LID - S0302-2838(12)01337-1 [pii]
LID - 10.1016/j.eururo.2012.11.006 [doi]
AB  - BACKGROUND: Rising prostate-specific antigen (PSA) levels after radical therapy 
      are indicative of recurrent or residual prostate cancer (PCa). This biochemical 
      recurrence typically predates clinically detectable metastatic disease by several 
      years. Management of patients with biochemical recurrence is controversial. 
      OBJECTIVE: To assess the effect of dutasteride on progression of PCa in patients 
      with biochemical failure after radical therapy. DESIGN, SETTING, AND 
      PARTICIPANTS: Randomised, double-blind, placebo-controlled trial in 294 men from 
      64 centres across 9 European countries. INTERVENTION: The 5alpha-reductase inhibitor, 
      dutasteride. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point 
      was time to PSA doubling from start of randomised treatment, analysed by log-rank 
      test stratified by previous therapy and investigative-site cluster. Secondary end 
      points included time to disease progression and the proportion of subjects with 
      disease progression. RESULTS AND LIMITATIONS: Of the 294 subjects randomised (147 
      in each treatment group), 187 (64%) completed 24 mo of treatment and 107 
      discontinued treatment prematurely (71 [48%] of the placebo group, 36 [24%] of 
      the dutasteride group). Dutasteride significantly delayed the time to PSA 
      doubling compared with placebo after 24 mo of treatment (p<0.001); the relative 
      risk (RR) reduction was 66.1% (95% confidence interval [CI], 50.35-76.90) for the 
      overall study period. Dutasteride also significantly delayed disease progression 
      (which included PSA- and non-PSA-related outcomes) compared with placebo 
      (p<0.001); the overall RR reduction in favour of dutasteride was 59% (95% CI, 
      32.53-75.09). The incidence of adverse events (AEs), serious AEs, and AEs leading 
      to study withdrawal were similar between the treatment groups. A limitation was 
      that investigators were not blinded to PSA levels during the study. CONCLUSIONS: 
      Dutasteride delayed the biochemical progression of PCa in patients with 
      biochemical failure after radical therapy for clinically localised disease. The 
      safety and tolerability of dutasteride were generally consistent with previous 
      experience. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov, NCT00558363.
CI  - Copyright (c) 2012 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Schroder, Fritz
AU  - Schroder F
AD  - Erasmus Medical Centre, Rotterdam, The Netherlands. secr.schroder@erasmusmc.nl
FAU - Bangma, Chris
AU  - Bangma C
FAU - Angulo, Javier C
AU  - Angulo JC
FAU - Alcaraz, Antonio
AU  - Alcaraz A
FAU - Colombel, Marc
AU  - Colombel M
FAU - McNicholas, Tom
AU  - McNicholas T
FAU - Tammela, Teuvo L
AU  - Tammela TL
FAU - Nandy, Indrani
AU  - Nandy I
FAU - Castro, Ramiro
AU  - Castro R
LA  - eng
SI  - ClinicalTrials.gov/NCT00558363
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121112
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (5-alpha Reductase Inhibitors)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Azasteroids)
RN  - EC 3.4.21.- (KLK3 protein, human)
RN  - EC 3.4.21.- (Kallikreins)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
RN  - O0J6XJN02I (Dutasteride)
SB  - IM
CIN - Nat Rev Urol. 2013 Feb;10(2):63. PMID: 23229506
CIN - Eur Urol. 2013 May;63(5):788-9; discussion 790-1. PMID: 23305882
CIN - J Urol. 2013 May;189(5):1716. PMID: 23594629
MH  - 5-alpha Reductase Inhibitors/*administration & dosage/adverse effects
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Hormonal/*administration & dosage/adverse effects
MH  - Azasteroids/*administration & dosage
MH  - Disease Progression
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Dutasteride
MH  - Europe
MH  - Humans
MH  - Kallikreins/*blood
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Grading
MH  - Proportional Hazards Models
MH  - Prostate-Specific Antigen/*blood
MH  - *Prostatectomy/adverse effects
MH  - Prostatic Neoplasms/blood/*drug therapy/pathology/*surgery
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - Up-Regulation
EDAT- 2012/11/28 06:00
MHDA- 2013/09/26 06:00
CRDT- 2012/11/27 06:00
PHST- 2012/09/11 00:00 [received]
PHST- 2012/11/04 00:00 [accepted]
PHST- 2012/11/27 06:00 [entrez]
PHST- 2012/11/28 06:00 [pubmed]
PHST- 2013/09/26 06:00 [medline]
AID - S0302-2838(12)01337-1 [pii]
AID - 10.1016/j.eururo.2012.11.006 [doi]
PST - ppublish
SO  - Eur Urol. 2013 May;63(5):779-87. doi: 10.1016/j.eururo.2012.11.006. Epub 2012 Nov 
      12.