Status:
COMPLETED
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Prostate Cancer
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 bicaluta...
Detailed Description
Permanent implant prostate brachytherapy is recognized as the treatment method for prostate cancer that results in the least amount of sexual side effects including erectile dysfunction (ED). However ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00866554
Start Date
March 1 2009
End Date
December 1 2019
Last Update
June 2 2023
Active Locations (1)
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1
CHUQ- Hotel-Dieu de Quebec
Québec, Quebec, Canada, G1R 2J6