Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | April 28, 2008 | ||||
Last Updated Date | June 24, 2011 | ||||
Start Date ICMJE | March 2007 | ||||
Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Level of U19 gene expression in tumor from prostate gland. [ Time Frame: Biopsy of prostate tumor during off-phase of intermittent androgen ablation therapy ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00668642 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Determination of PSA doubling time during off-phase of treatment [ Time Frame: Montly PSA measures during off-phase of treatment ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer | ||||
Official Title ICMJE | Effect of Dutasteride on Androgen-Response Gene Expression During the Tumor Regrowth Phase of Intermittent Androgen Ablation Therapy in Patients With Advanced Prostate Cancer | ||||
Brief Summary | The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy). |
||||
Detailed Description | We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. PSA levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
||||
Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | |||||
* 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 | Recruiting | ||||
Estimated Enrollment ICMJE | 28 | ||||
Estimated Completion Date | March 2014 | ||||
Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
|
||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00668642 | ||||
Other Study ID Numbers ICMJE | EH07-109 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Daniel H. Shevrin, MD/Senior Attending, NorthShore University HealthSystem | ||||
Study Sponsor ICMJE | NorthShore University HealthSystem Research Institute | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
Information Provided By | NorthShore University HealthSystem Research Institute | ||||
Verification Date | April 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |