Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 117 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866554
Recruitment Status : Unknown
Verified April 2015 by André-Guy Martin, CHU de Quebec-Universite Laval.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2009
Last Update Posted : April 16, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
André-Guy Martin, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE March 19, 2009
First Posted Date  ICMJE March 20, 2009
Last Update Posted Date April 16, 2015
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
Total prostate volume [ Time Frame: 3 months after start of therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00866554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
  • EPIC questionnaire urinary function and bother scores [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • EPIC questionnaire sexual function and bother scores [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • EPIC questionnaire bowel function and bother scores [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • EPIC questionnaire hormonal function and bother scores [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • IPSS scores [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • Acute urinary retention rates [ Time Frame: 0 to 6 months post-implant ]
  • SF-12 Quality of life questionnaire results [ Time Frame: baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • Rate of gynecomastia and breast tenderness [ Time Frame: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
  • Serum testosterone [ Time Frame: 3 months pre-implant, pre-implant, 3,6,12,18 and 24 months post-implant ]
  • Anemia [ Time Frame: baseline, pre-implant, 3,6,12,18 and 24 months post-implant ]
  • Abnormal liver function tests [ Time Frame: 6 weeks pre-implant, pre-implant, 3 months post-implant ]
  • Serum PSA [ Time Frame: baseline, pre-implant, 3,6,12,18 and 24 months post-implant ]
  • Adverse events recording [ Time Frame: 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy
Official Title  ICMJE Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy
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 bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.
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 prostate brachytherapy is often limited to patients with a prostate volume less than 50cc because of dosimetric and technical considerations. To counter this fact patients with a prostate larger than 50cc are offered neoadjuvant hormonal therapy to reduce their prostate volume to a value less than 50cc. The pharmacological method most often employed involves treatment with an LHRH agonist, which also involves multiple adverse effects for patients including ED in the majority of patients.

This approach may also involve other disadvantages including a possibility of increased cardiovascular mortality a possible increase in urinary toxicity and a reduction in health-related quality of life in patients treated with neoadjuvant hormonal therapy. Despite theses facts, neoadjuvant hormonal therapy remains essentially the sole method used to reduce prostate volume prior to prostate brachytherapy. One study has evaluated the efficacy of a neoadjuvant regimen without an LHRH agonist, comprised of Dutasteride and Bicalutamide to reduce prostate volume. This treatment could theoretically have fewer effects on sexual function and quality of life and could also possibly reduce urinary toxicity of brachytherapy. Nonetheless, these factors have never been evaluated. The cytoreductive efficacy of Bicalutamide and Dutasteride have never been directly compared to standard treatments. The current study is necessary to determine the effects of a neoadjuvant regimen of Bicalutamide and Dutasteride on prostate volume, sexual function, urinary toxicity and quality of life as compared to standard treatment. If it can be determined that there is an advantage with Bicalutamide and Dutasteride this regimen could become a standard of care for prostate cytoreduction prior to brachytherapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Erectile Dysfunction
  • Lower Urinary Tract Symptoms
Intervention  ICMJE
  • Drug: administration of a LHRH agonist and Bicalutamide
    3-month treatment with an LHRH agonist chosen by the treating radiation oncologist and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
    Other Name: Bicalutamide(Casodex)
  • Drug: administration of Bicalutamide, Dutasteride and Tamoxifen

    Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure.

    Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride

    Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.

    Other Names:
    • Bicalutamide (Casodex)
    • Dutasteride (Avodart)
    • Tamoxifen (Nolvadex)
Study Arms  ICMJE
  • Active Comparator: LHRH agonist
    Administration of a 3-month treatment with an LHRH agonist (chosen by the treating radiation oncologist) and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
    Intervention: Drug: administration of a LHRH agonist and Bicalutamide
  • Experimental: Dutasteride, Bicalutamide, Tamoxifen

    Administration of Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure.

    Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride

    Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.

    Intervention: Drug: administration of Bicalutamide, Dutasteride and Tamoxifen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 19, 2009)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00866554
Other Study ID Numbers  ICMJE DUT112661
Health Canada-112661 ( Other Grant/Funding Number: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party André-Guy Martin, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Andre-Guy Martin, MD CHUQ-Hotel-Dieu de Québec
PRS Account CHU de Quebec-Universite Laval
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP