TRADE-Testosterone Replacement and Dutasteride Effectiveness

NCT00194675 | Completed Phase 4 Results DMC

• 2 other identifiers: 0116601166, 4-2280-V
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia \[BPH\]) compared to T treatment alone in men with low testosterone (called hypogonadism).

Conditions

Hypogonadism; Benign Prostatic Hyperplasia

Keywords

androgen deficiency; testosterone; Benign Prostatic Hyperplasia; hypogonadism; prostate; BPH

Outcome Measures

Primary Outcomes (1)

• Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.

  Baseline, Month 6

Secondary Outcomes (5)

• Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)

  Baseline, Month 6

• 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)

  Baseline, Month 3, Month 6

• Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)

  Baseline, 3-months, 6-months

• Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume

  Baseline, 3-months, 6-months

• Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.

  Baseline, 3-months, 6-months

Study Arms (2)

Testosterone gel + oral placebo

ACTIVE COMPARATOR

Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily

Drug: Testosterone gel; Drug: Placebo dutasteride

Testosterone gel + oral dutasteride

ACTIVE COMPARATOR

Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily

Drug: Dutasteride; Drug: Testosterone gel

Interventions

Dutasteride DRUG

Dutasteride 0.5 mg orally daily

Also known as: AndroGel

Testosterone gel + oral dutasteride

Testosterone gel DRUG

Testosterone gel 7.5 g daily topical

Also known as: Testim

Testosterone gel + oral dutasteride; Testosterone gel + oral placebo

Placebo dutasteride DRUG

placebo dutasteride orally daily

Testosterone gel + oral placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy older men 50 years old or older
• 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.

You may not qualify if:

• A history of prostate or breast cancer
• 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.

Sponsors & Collaborators

• University of Washington: lead
• GlaxoSmithKline: collaborator
• Seattle Institute for Biomedical and Clinical Research: collaborator
• VA Office of Research and Development: collaborator
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (11)

• 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.

  PMID: 12534854 BACKGROUND

• 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.

  PMID: 12787549 BACKGROUND

• 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.

  PMID: 11318778 BACKGROUND

• 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.

  PMID: 7514512 BACKGROUND

• 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.

  PMID: 4625049 BACKGROUND

• 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.

  PMID: 12721204 BACKGROUND

• 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.

  PMID: 8968017 BACKGROUND

• 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.

  PMID: 11304729 BACKGROUND

• 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.

  PMID: 12824459 BACKGROUND

• 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.

  PMID: 11297606 BACKGROUND

• 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.

  PMID: 21575967 RESULT

MeSH Terms

Conditions

Hypogonadism; Prostatic Hyperplasia

Interventions

Dutasteride; Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstenols; Androstenes; Androstanes; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Alvin M. Matsumoto, MD
• Organization: VA Puget Sound Health Care System

alvin.matsumoto@med.va.gov

(206) 764-2760

Study Officials

• Alvin M Matsumoto, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: March 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 5, 2017
• Results First Posted: August 20, 2012

Record last verified: 2017-10

Locations

US (1)