TRADE-Testosterone Replacement and Dutasteride Effectiveness (TRADE)

October 30, 2017 updated by: Alvin M. Matsumoto, MD, University of Washington

Testosterone Replacement and Dutasteride Effectiveness (TRADE)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Weight more than 300 lbs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Testosterone gel + oral placebo
Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily
Drug: Testosterone gel
Testosterone gel 7.5 g daily topical
Other Names:
  • Testim
Drug: Placebo dutasteride
placebo dutasteride orally daily
Active Comparator: Testosterone gel + oral dutasteride
Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily
Drug: Testosterone gel
Testosterone gel 7.5 g daily topical
Other Names:
  • Testim
Drug: Dutasteride
Dutasteride 0.5 mg orally daily
Other Names:
  • AndroGel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Time Frame: Baseline, Month 6
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)
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.
Baseline, Month 3, Month 6
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Time Frame: Baseline, 3-months, 6-months
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
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
Baseline, 3-months, 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

GlaxoSmithKline
VA Office of Research and Development
Seattle Institute for Biomedical and Clinical Research
Solvay Pharmaceuticals

Investigators

  • Principal Investigator: Alvin M Matsumoto, MD, VA Puget Sound Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01166
  • 01166, 4-2280-V (Other Identifier: VA Puget Sound Health Care System Human Subject Division)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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