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

NCT ID: NCT01327495

Last Updated: 2017-10-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1: Placebo

Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks

Group Type PLACEBO_COMPARATOR

placebo acyline

Intervention Type OTHER

Placebo acyline subcutaneous injection every 2 weeks

placebo gel

Intervention Type OTHER

daily placebo testosterone gel applied transdermally x 12 weeks

Arm 2:1.25g Testosterone

Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks

Group Type ACTIVE_COMPARATOR

Testosterone 1% gel 1.25 g

Intervention Type DRUG

testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks

Acyline

Intervention Type DRUG

300 ug/kg subcutaneous injection every 2 weeks

Arm 3: 2.5g Testosterone

Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks

Group Type ACTIVE_COMPARATOR

Testosterone 1% gel 2.5 g

Intervention Type DRUG

Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks

Acyline

Intervention Type DRUG

300 ug/kg subcutaneous injection every 2 weeks

Arm 4: 5g Testosterone

Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks

Group Type ACTIVE_COMPARATOR

Testosterone 1% gel 5.0 g

Intervention Type DRUG

Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks

Acyline

Intervention Type DRUG

300 ug/kg subcutaneous injection every 2 weeks

Arm 5: 10g Testosterone

Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks

Group Type ACTIVE_COMPARATOR

testosterone 1% gel 10 g

Intervention Type DRUG

Testosterone 1% gel 10 g daily applied transdermally x 12 weeks

Acyline

Intervention Type DRUG

300 ug/kg subcutaneous injection every 2 weeks

Arm 6: 15g Testosterone

Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks

Group Type ACTIVE_COMPARATOR

testosterone 1% gel 15 g

Intervention Type DRUG

Testosterone 1% gel 15 g daily applied transdermally x 12 weeks

Acyline

Intervention Type DRUG

300 ug/kg subcutaneous injection every 2 weeks

Interventions

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placebo acyline

Placebo acyline subcutaneous injection every 2 weeks

Intervention Type OTHER

placebo gel

daily placebo testosterone gel applied transdermally x 12 weeks

Intervention Type OTHER

Testosterone 1% gel 1.25 g

testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks

Intervention Type DRUG

Testosterone 1% gel 2.5 g

Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks

Intervention Type DRUG

Testosterone 1% gel 5.0 g

Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks

Intervention Type DRUG

testosterone 1% gel 10 g

Testosterone 1% gel 10 g daily applied transdermally x 12 weeks

Intervention Type DRUG

testosterone 1% gel 15 g

Testosterone 1% gel 15 g daily applied transdermally x 12 weeks

Intervention Type DRUG

Acyline

300 ug/kg subcutaneous injection every 2 weeks

Intervention Type DRUG

Other Intervention Names

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placebo placebo Androgel Androgel Androgel Androgel Androgel GNRH antagonist

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Stephanie T. Page

Professor Department of Medicine, Division of Metabolism, Endocrinology and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephanie T Page, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Thirumalai A, Cooper LA, Rubinow KB, Amory JK, Lin DW, Wright JL, Marck BT, Matsumoto AM, Page ST. Stable Intraprostatic Dihydrotestosterone in Healthy Medically Castrate Men Treated With Exogenous Testosterone. J Clin Endocrinol Metab. 2016 Jul;101(7):2937-44. doi: 10.1210/jc.2016-1483. Epub 2016 May 12.

Reference Type RESULT
PMID: 27172434 (View on PubMed)

Other Identifiers

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1R01AG037603-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

39738

Identifier Type: -

Identifier Source: org_study_id