title: Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer.
abstract: BACKGROUND
  Guidelines for prostate cancer treatment suggest that intermittent androgen deprivation (IAD) can be considered for certain patients.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of degarelix as IAD for one or more treatment cycle(s) in prostate cancer patients requiring androgen deprivation.
  
  
  METHODS
  This open-label uncontrolled multicenter study included patients with prostate-specific antigen (PSA) >4 to 50 ng/ml or PSA doubling time <24 mo. Induction included 7-mo treatment. Off-treatment period started when PSA was ≤4 ng/ml and lasted up to 24 mo based on PSA and testosterone levels. Treatment was reinitiated when PSA was >4 ng/ml.
  
  
  METHODS
  Each induction period included a starting dose of degarelix 240mg, and thereafter 80mg once a month for 6 mo, followed by off-treatment periods.
  
  
  METHODS
  The primary end point was time to PSA >4 ng/ml. Secondary end points were subgroup analysis of the primary end point, time to testosterone >0.5 and >2.2 ng/ml, quality of life (QoL), and sexual function during the first off-treatment period.
  
  
  CONCLUSIONS
  Of 213 patients in the first induction period, 191 entered the first off-treatment period, 35 patients entered the second induction, and 30 entered the second off-treatment period. Only two patients entered the third cycle. Median time to PSA >4 ng/ml and duration of first off-treatment period was 392 d each. Significant differences in time to PSA >4 ng/ml were observed between subgroups stratified by prognostic factors (previous curative treatment, cancer stage, PSA levels, and Gleason scores). Time to testosterone >0.5 and >2.2 ng/ml was 112 and 168 d, respectively. Change in QoL remained nonsignificant, and sexual function gradually improved during the off-treatment period. Adverse events were fewer during the off-treatment period and subsequent treatment cycles.
  
  
  CONCLUSIONS
  IAD with degarelix resulted in an improvement in sexual function commensurate with increased testosterone levels while PSA remained suppressed. The treatment for one treatment cycle or more was well tolerated.
  
  
  RESULTS
  Guidelines for prostate cancer treatment suggest that intermittent androgen deprivation (IAD) can be considered for certain patients. IAD with degarelix resulted in improved sexual function commensurate with increased testosterone levels while prostate-specific antigen remained suppressed. The treatment for one treatment cycle or more was well tolerated.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier NCT00801242.
authors: Membre de l'Académie de Chirurgie, Expert près les Tribunaux, Paris, France.
authors: Laurent
authors: L
authors: Boccon-Gibod
authors: Department of Urology, Düsseldorf University Hospital, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
authors: Peter
authors: P
authors: Albers
authors: Department of Urology, Vall d'Hebron Hospital, Universitat Autónoma de Barcelona, Barcelona, Spain.
authors: Juan
authors: J
authors: Morote
authors: Department of Urology, University Hospitals of the KU Leuven, UZ Leuven, Leuven, Belgium.
authors: Hendrik
authors: H
authors: van Poppel
authors: Department of Urology G4-172, AMC University Hospital, Amsterdam, The Netherlands.
authors: Jean
authors: J
authors: de la Rosette
authors: Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
authors: Arnauld
authors: A
authors: Villers
authors: Ferring Pharmaceuticals A/S, Clin R&D, Global Biometrics, Copenhagen, Denmark.
authors: Anders
authors: A
authors: Malmberg
authors: Ferring Pharmaceuticals A/S, Clin R&D, Urology, Copenhagen, Denmark.
authors: Anders
authors: A
authors: Neijber
authors: Cattedra di Urologia, Università Vita e Salute San Raffaele, Milan, Italy. Electronic address: montorsi.francesco@hsr.it.
authors: Francesco
authors: F
authors: Montorsi
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009361:Neoplasm Invasiveness / Q000473:pathology; D009842:Oligopeptides / Q000008:administration & dosage*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood / Q000187:drug effects*; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology*; D011788:Quality of Life; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D009842:Oligopeptides; C431566:acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; D013739:Testosterone; D017430:Prostate-Specific Antigen
keywords: Efficacy; GnRH antagonist; Intermittent androgen deprivation; Prostate cancer; safety