Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if a combination of neoadjuvant dutasteride and bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Collaborator: GlaxoSmithKline
• Treatments: Bicalutamide; Dutasteride; Tamoxifen

Criteria

Inclusion Criteria:

• Male sex

• Diagnosis of prostate adenocarcinoma as confirmed by prostate biopsy

• Prostate cancer with stage T1a, T1b T2a or T2b Nx Mx as determined by clinical examination

• Gleason score of 6 or less or 7 (3+4)*

• If Gleason score is 7(3+4) patient must have less than 30% of biopsied tissue positive

• Serum PSA of ≤ 15ng/ml during the month before study entry

• Prostate volume ≥ 45cc

• Normal serum testosterone during the month before study entry

• Availability for treatment and follow-up visits

• Having signed required consent form before study entry

Exclusion Criteria:

• Abnormal Liver Function tests (>2x normal AST or ALT and/or >1.5x normal bilirubin)

• Prostate volume less than 50 cc

• History of hormonal treatment including any of the above: LHRH agonists, antiandrogens during the year before study entry

• Use of a 5 alpha reductase inhibitor for more than one month during the year prior to study entry

• History of pelvic irradiation

• History of past chemotherapy

• History of TURP

• History of past treatment for prostate cancer

• Known hypersensitivity to Dutasteride or Bicalutamide

• Co-morbid disease possibly compromising treatment compliance

• History of DVT or pulmonary embolism

• Anticoagulation with coumarin

• Inability to give consent