TRADE-Testosterone Replacement and Dutasteride Effectiveness
NCT ID: NCT00194675
Last Updated: 2017-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
53 participants
INTERVENTIONAL
2005-03-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Testosterone gel + oral placebo
Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily
Testosterone gel
Testosterone gel 7.5 g daily topical
Placebo dutasteride
placebo dutasteride orally daily
Testosterone gel + oral dutasteride
Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily
Dutasteride
Dutasteride 0.5 mg orally daily
Testosterone gel
Testosterone gel 7.5 g daily topical
Interventions
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Dutasteride
Dutasteride 0.5 mg orally daily
Testosterone gel
Testosterone gel 7.5 g daily topical
Placebo dutasteride
placebo dutasteride orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an average of equal to or less than 300 ng/dl on two occasions)
* Prostate volume equal to or more than 30 cc by prostate MRI
* Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less than 10 ng/mL
* Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy
* International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than or equal to 20 at screening
* Comply with study procedures for the full 10 months
* No contraindications to MRI
Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and University of Washington Medical Center in Seattle.
Exclusion Criteria
* Invasive therapy for BPH in the past
* History of acute urinary retention in the 3 months prior to screening
* Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride)
* Medical therapy for BPH within the past month (alpha-blocker, phytotherapy)
* Use of androgenic or antiandrogenic drugs in the past year
* History or evidence of prostate cancer including suspicious DRE or history of high-grade PIN on prostate biopsy.
* Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes)
* Known untreated obstructive sleep apnea
* Hematocrit greater than 52
* Severe skin disease which may interfere with testosterone gel absorption
* Hypersensitivity to any of the drugs used in the study
* History of a bleeding disorder or need for chronic anticoagulation
* Participation in a drug study concurrently or in the last 90 days
* History or current evidence of drug or alcohol abuse within 12 mo.
* Weight more than 300 lbs.
50 Years
MALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Seattle Institute for Biomedical and Clinical Research
OTHER
VA Office of Research and Development
FED
Solvay Pharmaceuticals
INDUSTRY
University of Washington
OTHER
Responsible Party
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Alvin M. Matsumoto, MD
Professor
Principal Investigators
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Alvin M Matsumoto, MD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Locations
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VA Puget Sound Health Care System
Seattle, Washington, United States
Countries
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References
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Gruenewald DA, Matsumoto AM. Testosterone supplementation therapy for older men: potential benefits and risks. J Am Geriatr Soc. 2003 Jan;51(1):101-15; discussion 115. doi: 10.1034/j.1601-5215.2002.51018.x.
Yialamas MA, Hayes FJ. Androgens and the ageing male and female. Best Pract Res Clin Endocrinol Metab. 2003 Jun;17(2):223-36. doi: 10.1016/s1521-690x(03)00018-6.
Jin B, Conway AJ, Handelsman DJ. Effects of androgen deficiency and replacement on prostate zonal volumes. Clin Endocrinol (Oxf). 2001 Apr;54(4):437-45. doi: 10.1046/j.1365-2265.2001.01240.x.
Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x.
Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available.
Bhasin S, Singh AB, Mac RP, Carter B, Lee MI, Cunningham GR. Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan. J Androl. 2003 May-Jun;24(3):299-311. doi: 10.1002/j.1939-4640.2003.tb02676.x. No abstract available.
Morgentaler A, Bruning CO 3rd, DeWolf WC. Occult prostate cancer in men with low serum testosterone levels. JAMA. 1996 Dec 18;276(23):1904-6.
Schatzl G, Madersbacher S, Thurridl T, Waldmuller J, Kramer G, Haitel A, Marberger M. High-grade prostate cancer is associated with low serum testosterone levels. Prostate. 2001 Apr;47(1):52-8. doi: 10.1002/pros.1046.
Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24.
Monti S, Di Silverio F, Iraci R, Martini C, Lanzara S, Falasca P, Poggi M, Stigliano A, Sciarra F, Toscano V. Regional variations of insulin-like growth factor I (IGF-I), IGF-II, and receptor type I in benign prostatic hyperplasia tissue and their correlation with intraprostatic androgens. J Clin Endocrinol Metab. 2001 Apr;86(4):1700-6. doi: 10.1210/jcem.86.4.7413.
Page ST, Hirano L, Gilchriest J, Dighe M, Amory JK, Marck BT, Matsumoto AM. Dutasteride reduces prostate size and prostate specific antigen in older hypogonadal men with benign prostatic hyperplasia undergoing testosterone replacement therapy. J Urol. 2011 Jul;186(1):191-7. doi: 10.1016/j.juro.2011.03.026. Epub 2011 May 14.
Other Identifiers
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01166, 4-2280-V
Identifier Type: OTHER
Identifier Source: secondary_id
01166
Identifier Type: -
Identifier Source: org_study_id