PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate

This study is currently recruiting participants.
Verified February 2014 by University of Washington
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Stephanie T. Page, University of Washington
ClinicalTrials.gov Identifier:
NCT01327495
First received: March 21, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The investigators will conduct a three-month, randomized, placebo-controlled trial comparing the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the prostate in healthy men who are treated with acyline to block gonadal androgen production.


Condition Intervention Phase
Healthy
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Prostate tissue DHT concentrations after treatment [ Time Frame: A prostate biopsy will be performed at week 12 to measure intraprostatic dihydrotestosterone [DHT] levels. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Placebo acyline every 2 weeks + daily placebo gel x 12 weeks
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
  1. Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks
  2. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
  3. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
  4. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
  5. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks
  6. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
Active Comparator: Arm 2
Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
  1. Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks
  2. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
  3. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
  4. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
  5. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks
  6. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
Active Comparator: Arm 3
Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
  1. Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks
  2. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
  3. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
  4. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
  5. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks
  6. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
Active Comparator: Arm 4
Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
  1. Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks
  2. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
  3. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
  4. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
  5. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks
  6. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
Active Comparator: Arm 5
Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
  1. Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks
  2. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
  3. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
  4. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
  5. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks
  6. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
Active Comparator: Arm 6
Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks
Drug: Testosterone 1% gel (or placebo) + acyline (or placebo)
  1. Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks
  2. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
  3. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
  4. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
  5. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks
  6. Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks

Detailed Description:

The investigators overall goals are (i) to determine the relationship between serum and prostate tissue hormone concentrations in men in response to increasing doses of exogenous androgens; (ii) to determine the impact that alterations in serum and tissue testosterone concentrations have on prostate epithelial cell function and phenotype; and (iii) to determine the relationships between prostatic androgens and alterations in the tissue microenvironment. The investigators will perform a study in healthy, middle-aged men to address the following Specific Aims:

Specific Aims: To compare the dose-response relationships between serum testosterone and intraprostatic androgens and androgen action, and serum testosterone and anabolic activity in healthy, middle-aged men.

Hypothesis: The investigators hypothesize that very low levels of serum testosterone will lower concentrations of intraprostatic testosterone and dihydrotestosterone (DHT). However, when serum testosterone concentrations are within or even above the normal range there will be no significant increases in intraprostatic testosterone and dihydrotestosterone. In contrast, the investigators expect that anabolic activity will increase with increasing concentrations of circulating testosterone.

Secondarily, the investigators hypothesize that increasing levels of serum testosterone beyond the low normal range will have little impact on androgen action within the prostate.

Approach: The investigators will conduct a randomized, placebo-controlled trial in healthy men who are medically castrated and administered one of five different doses of testosterone gel (Androgel) for 12 weeks.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In good health, without severe systemic illness (i.e., renal, liver, cardiac or lung disease, cancer, insulin dependent diabetes)

  • Male between the ages of 25 and 55 years old
  • Able to understand and comply with protocol instructions and requirements
  • International Prostate Symptom Score (IPSS) <11
  • Agrees to not donate blood during the study
  • Normal serum total T, LH, FSH, urine analysis, COMP, CBC and sperm count

Exclusion Criteria:

  • History of, or current breast cancer or prostate cancer
  • Clinically significant findings on digital rectal exam such as nodules, areas of induration or any other malignancy or abnormal prostate ultrasound
  • History of invasive therapy for BPH
  • Current or past treatment with a 5α-reductase inhibitor
  • History of drug or alcohol abuse within the past 12 months
  • History of a bleeding disorder or anticoagulation
  • Skin disease that might interfere with T-gel absorption
  • Participation in another drug study in the past 3 months
  • A first-degree relative (i.e. father, brother) with a history of prostate cancer
  • History of infertility or desire for fertility within 6 months, or current pregnant female partner
  • Weight >320 pounds or BMI > 40
  • PSA Level > 2.1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327495

Contacts
Contact: Kathryn T Duncan, BA 206.616.0482 kymmkatt@uw.edu
Contact: Iris Nielsen 206.221.5473 nielseni@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Kathryn T Duncan, BA    206-616-0482    kymmkatt@uw.edu   
Contact: Kathy L Winter    206.616.0484    klwinter@u.washington.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Stephanie T Page, MD, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Stephanie T. Page, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01327495     History of Changes
Other Study ID Numbers: 39738-A, 1R01AG037603-01
Study First Received: March 21, 2011
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Androgen replacement in men

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 22, 2014