title: Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects.
abstract: BACKGROUND
  Intermittent dosing may reduce the adverse events (AEs) of androgen-deprivation therapy (ADT).
  
  
  OBJECTIVE
  To compare intermittent androgen deprivation (IAD) and continuous androgen deprivation (CAD) with regard to health-related quality of life (QoL).
  
  
  METHODS
  A total of 852 men with advanced prostate cancer (PCa) were enrolled to receive goserelin acetate 3.6 mg every 28 d for 24 wk. A total of 554 patients whose prostate-specific antigen (PSA) decreased to <10 ng/ml or by ≥50% (<20 ng/ml at baseline) were randomised to IAD or CAD.
  
  
  METHODS
  In the IAD arm, ADT was resumed for at least 24 wk whenever PSA increased >20 ng/ml or above baseline.
  
  
  METHODS
  QoL was monitored with a validated Cleary 30-item questionnaire and analysed by the Mann-Whitney U test, 0.5 standard deviation rule, and repeated measures analysis of variance. AEs and adverse drug reactions (ADRs) were analysed by the chi-square test.
  
  
  CONCLUSIONS
  Median follow-up was 65 mo. Significant differences in QoL emerged in activity limitation, physical capacity, and sexual functioning, favouring IAD. No significant differences emerged in the prevalence of AEs: 87 patients in the IAD arm (31.8%) and 95 in the CAD arm (33.9%) had cardiovascular (CV) AEs (p=0.59), with 25 (9.1%) and 29 (10.4%) withdrawn (p=0.62), and 21 (7.7%) and 24 (8.6%) dying because of a CV event (p=0.70), respectively; bone fractures occurred in 19 (6.9%) and 15 (5.4%) patients (p=0.44), respectively. Hot flushes or night sweats were the most common ADRs (47.1% vs 50.4%; p=0.44). Erectile dysfunction (15.7% vs 7.9%; p=0.042) and depressed mood (2.2 vs 0%; p=0.032) were more common in the IAD arm.
  
  
  CONCLUSIONS
  IAD showed benefits in the treatment of advanced PCa with respect to QoL. The prevalence of AEs was not significantly lower with IAD.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT00293670.
authors.affiliation: Department of Urology, Kuopio University Hospital, Finland. arto.salonen@kuh.fi
authors.forename: Arto J
authors.initials: AJ
authors.lastname: Salonen
authors.forename: Kimmo
authors.initials: K
authors.lastname: Taari
authors.forename: Martti
authors.initials: M
authors.lastname: Ala-Opas
authors.forename: Jouko
authors.initials: J
authors.lastname: Viitanen
authors.forename: Seppo
authors.initials: S
authors.lastname: Lundstedt
authors.forename: Teuvo L J
authors.initials: TL
authors.lastname: Tammela
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000726:Androgen Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004334:Drug Administration Schedule; D005387:Finland; D017273:Goserelin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007610:Kallikreins / Q000097:blood; D008297:Male; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D009376:Neoplasms, Hormone-Dependent / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000037:antagonists & inhibitors* / Q000097:blood; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D013739:Testosterone; C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen