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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01327495
First Posted: April 1, 2011
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Stephanie T. Page, University of Washington
  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 Other: placebo acyline Other: placebo gel Drug: Testosterone 1% gel 1.25 g Drug: Testosterone 1% gel 2.5 g Drug: Testosterone 1% gel 5.0 g Drug: testosterone 1% gel 10 g Drug: testosterone 1% gel 15 g Drug: Acyline Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Stephanie T. Page, University of Washington:

Primary Outcome Measures:
  • Prostate Tissue DHT Concentrations After Treatment [ Time Frame: 12 weeks ]
    To measure intraprostatic dihydrotestosterone [DHT] levels

  • Serum Testosterone [ Time Frame: 12 weeks ]
  • Dihydrotestosterone (DHT) [ Time Frame: 12 weeks ]
  • Prostate Tissue Testosterone Concentrations After Treatment [ Time Frame: 12 weeks ]
    To measure intraprostatic testosterone levels


Secondary Outcome Measures:
  • Prostate Specific Antigen [ Time Frame: 12 weeks ]
  • Prostate Volume [ Time Frame: 12 weeks ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ]
    IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic


Other Outcome Measures:
  • 17-OHPreg [ Time Frame: 12 weeks ]
  • 17-OHP [ Time Frame: 12 weeks ]
  • Androstenedione [ Time Frame: 12 weeks ]
  • Androsterone [ Time Frame: 12 weeks ]
  • DHEA [ Time Frame: 12 weeks ]
  • Pregnenolone [ Time Frame: 12 weeks ]
  • Progesterone [ Time Frame: 12 weeks ]

Enrollment: 62
Actual Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1: Placebo
Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks
Other: placebo acyline
Placebo acyline subcutaneous injection every 2 weeks
Other Name: placebo
Other: placebo gel
daily placebo testosterone gel applied transdermally x 12 weeks
Other Name: placebo
Active Comparator: Arm 2:1.25g Testosterone
Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks
Drug: Testosterone 1% gel 1.25 g
testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
Other Name: Androgel
Drug: Acyline
300 ug/kg subcutaneous injection every 2 weeks
Other Name: GNRH antagonist
Active Comparator: Arm 3: 2.5g Testosterone
Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks
Drug: Testosterone 1% gel 2.5 g
Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
Other Name: Androgel
Drug: Acyline
300 ug/kg subcutaneous injection every 2 weeks
Other Name: GNRH antagonist
Active Comparator: Arm 4: 5g Testosterone
Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks
Drug: Testosterone 1% gel 5.0 g
Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
Other Name: Androgel
Drug: Acyline
300 ug/kg subcutaneous injection every 2 weeks
Other Name: GNRH antagonist
Active Comparator: Arm 5: 10g Testosterone
Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks
Drug: testosterone 1% gel 10 g
Testosterone 1% gel 10 g daily applied transdermally x 12 weeks
Other Name: Androgel
Drug: Acyline
300 ug/kg subcutaneous injection every 2 weeks
Other Name: GNRH antagonist
Active Comparator: Arm 6: 15g Testosterone
Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks
Drug: testosterone 1% gel 15 g
Testosterone 1% gel 15 g daily applied transdermally x 12 weeks
Other Name: Androgel
Drug: Acyline
300 ug/kg subcutaneous injection every 2 weeks
Other Name: GNRH antagonist

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327495


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Stephanie T Page, MD, PhD University of Washington
  More Information

Additional Information:
Publications:
Responsible Party: Stephanie T. Page, Professor Department of Medicine, Division of Metabolism, Endocrinology and Nutrition, University of Washington
ClinicalTrials.gov Identifier: NCT01327495     History of Changes
Other Study ID Numbers: 39738
1R01AG037603-01 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2011
First Posted: April 1, 2011
Results First Submitted: February 15, 2017
Results First Posted: October 5, 2017
Last Update Posted: October 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stephanie T. Page, 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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents