title: Randomized non-inferiority trial of Bicalutamide and Dutasteride versus LHRH agonists for prostate volume reduction prior to I-125 permanent implant brachytherapy for prostate cancer.
abstract: OBJECTIVE
  To determine the efficacy and toxicity of a 3-month regimen of Dutasteride and Bicalutamide compared to LHRH agonists for prostate volume (PV) reduction prior to permanent implant prostate brachytherapy (PIPB).
  
  
  METHODS
  Patients with low-risk or low-tier intermediate risk prostate cancer eligible for PIPB with a prostate volume greater than 50 cc were randomized to either Dutasteride 0.5 mg Bicalutamide 50 mg daily and Tamoxifen 10 mg daily for 3 months (D+B group) or to a 3 month dose of an LHRH agonist and Bicalutamide daily for 1 month (LHRH group). Their PV was measured at baseline and at pre-implant. Non-inferiority analysis was completed for the relative (%) PV reduction. IPSS and EPIC questionnaires were completed at baseline, pre-implant and at 1, 3, 6, 12, 18 and 24 months post-treatment. IPSS and EPIC comparisons were based on superiority analysis
  
  
  RESULTS
  60 patients were randomized (31 to LHRH group and 29 to D+B group). Mean relative PV reduction (SD) was 35.5% (8.9) in the LHRH group and 31.7% (9.6) in the D+B group. The upper bound of the 95% confidence for the interval for the difference between groups favouring LHRH agonists for PV reduction was 8.6 which did not cross the 10% non-inferiority margin meaning D+B is non-inferior to LHRH agonist for PV reduction, although 5/29 (17%) of those in the D+B group required longer duration of D+B to achieve adequate volume reduction. There were no statistically significant differences in IPSS scores over the entire follow-up period. EPIC sexual summary score was significantly better in the D+B group at pre-implant, 1 month, 3 months post-implant.
  
  
  CONCLUSIONS
  Dutasteride and Bicalutamide is a regimen of non-inferior efficacy to LHRH agonist based regimens for prostate volume reduction prior to permanent implant prostate brachytherapy. D+B has less sexual toxicity compared to LHRH agonists prior to implant and for the first 6 months after implant. D+B is therefore an option to be considered for prostate volume reduction prior to PIPB.
authors.affiliation: Radiation Oncology, Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec, Canada; Radiation Oncology, Centre Intégré de Santé et Services Sociaux de l'Outaouais, Gatineau, Canada. Electronic address: marcgaudet@ssss.gouv.qc.ca.
authors.forename: Marc
authors.initials: M
authors.lastname: Gaudet
authors.affiliation: Radiation Oncology, Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec, Canada; Centre de recherche sur le cancer de l'Université Laval, Québec, Canada.
authors.forename: Éric
authors.initials: É
authors.lastname: Vigneault
authors.affiliation: Radiation Oncology, Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec, Canada.
authors.forename: William
authors.initials: W
authors.lastname: Foster
authors.affiliation: Centre de recherche sur le cancer de l'Université Laval, Québec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Meyer
authors.affiliation: Radiation Oncology, Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec, Canada; Centre de recherche sur le cancer de l'Université Laval, Québec, Canada.
authors.forename: André-Guy
authors.initials: AG
authors.lastname: Martin
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000813:Anilides / Q000627:therapeutic use*; D001918:Brachytherapy; D000068538:Dutasteride / Q000627:therapeutic use*; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000628:therapy*; D013739:Testosterone / Q000097:blood; D014105:Tosyl Compounds / Q000627:therapeutic use*
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D007457:Iodine Radioisotopes; D009570:Nitriles; D014105:Tosyl Compounds; D007987:Gonadotropin-Releasing Hormone; D013739:Testosterone; C053541:bicalutamide; D000068538:Dutasteride
keywords: Bicalutamide; Brachytherapy; Cytoreduction; Dutasteride; Prostate