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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
March 21, 2011
April 1, 2011
February 15, 2017
October 5, 2017
October 5, 2017
October 2011
June 2014   (Final data collection date for primary outcome measure)
  • 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
Relationship between serum testosterone concentration and intraprostatic dihydrotestosterone level [ Time Frame: A prostate biopsy will be performed at week 12 to determine intraprostatic dihydrotestosterone level. ]
Complete list of historical versions of study NCT01327495 on ClinicalTrials.gov Archive Site
  • 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
The relationship between serum testosterone and intraprostatic testosterone [ Time Frame: A prostate biopsy will be performed at week 12 to determine intraprostatic testosterone level. ]
  • 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 ]
Not Provided
 
PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
  • Drug: Testosterone 1% gel 1.25 g
    testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
    Other Name: Androgel
  • Drug: Testosterone 1% gel 2.5 g
    Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
    Other Name: Androgel
  • Drug: Testosterone 1% gel 5.0 g
    Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
    Other Name: Androgel
  • Drug: testosterone 1% gel 10 g
    Testosterone 1% gel 10 g daily applied transdermally x 12 weeks
    Other Name: Androgel
  • 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
  • Placebo Comparator: Arm 1: Placebo
    Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks
    Interventions:
    • Other: placebo acyline
    • Other: placebo gel
  • Active Comparator: Arm 2:1.25g Testosterone
    Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks
    Interventions:
    • Drug: Testosterone 1% gel 1.25 g
    • Drug: Acyline
  • Active Comparator: Arm 3: 2.5g Testosterone
    Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks
    Interventions:
    • Drug: Testosterone 1% gel 2.5 g
    • Drug: Acyline
  • Active Comparator: Arm 4: 5g Testosterone
    Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks
    Interventions:
    • Drug: Testosterone 1% gel 5.0 g
    • Drug: Acyline
  • Active Comparator: Arm 5: 10g Testosterone
    Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks
    Interventions:
    • Drug: testosterone 1% gel 10 g
    • Drug: Acyline
  • Active Comparator: Arm 6: 15g Testosterone
    Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks
    Interventions:
    • Drug: testosterone 1% gel 15 g
    • Drug: Acyline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
December 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
25 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01327495
39738
1R01AG037603-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Stephanie T. Page, University of Washington
University of Washington
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
Principal Investigator: Stephanie T Page, MD, PhD University of Washington
University of Washington
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP