TRADE-Testosterone Replacement and Dutasteride Effectiveness (TRADE)
|Hypogonadism Benign Prostatic Hyperplasia||Drug: Dutasteride Drug: Testosterone gel Drug: Placebo dutasteride||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Testosterone Replacement and Dutasteride Effectiveness (TRADE)|
- Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia. [ Time Frame: Baseline, Month 6 ]
- Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA) [ Time Frame: Baseline, Month 6 ]
- Androgen-responsive Gene Expression and Proliferation in the Stromal and Epithelial Compartments of the Prostate [ Time Frame: 6-months ]
- The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score) [ Time Frame: Baseline, Month 3, Month 6 ]International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.
- Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow) [ Time Frame: Baseline, 3-months, 6-months ]
- Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume [ Time Frame: Baseline, 3-months, 6-months ]
- Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione. [ Time Frame: Baseline, 3-months, 6-months ]
|Study Start Date:||March 2005|
|Study Completion Date:||December 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Testosterone + oral placebo
Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily
Drug: Testosterone gel
Testosterone gel 7.5 g daily topical
Other Name: TestimDrug: Placebo dutasteride
placebo dutasteride orally daily
Active Comparator: Testosterone + oral dutasteride
Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily
Dutasteride 0.5 mg orally daily
Other Name: AndroGelDrug: Testosterone gel
Testosterone gel 7.5 g daily topical
Other Name: Testim
The primary aim of this study is to determine whether correction of hypogonadism using a combination of testosterone and dutasteride spares subjects from increases in prostate size and symptoms of BPH which may be associated with T alone.
We will also determine the effects of changes in serum T and dihydrotestosterone (DHT) on both the hormonal milieu and genetic program within the prostate gland itself. The technology employed will allow us to determine which genes are androgen responsive within each prostate tissue compartment. Together, these data may determine whether the combination of testosterone and dutasteride safely corrects the symptoms of BPH and hypogonadism and minimizes growth stimulus to the prostate at the genetic level. We will also assess the effects of the combination of T and dutasteride on cognitive function.
This is a six-month, double-blind, randomized, placebo-controlled, single-site study of older hypogonadal men with mild to moderate BPH.
Within each treatment group, a sub-group of subjects will undergo additional procedures as part of a Prostate Biopsy sub-study to obtain prostate tissue for hormonal and genetic analyses. Selection of subjects will be based on clinical indication and/or willingness to undergo prostate biopsies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194675
|United States, Washington|
|VA Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Alvin M Matsumoto, MD||VA Puget Sound Health Care System|