HealthyPhase 2/3PROS-2NCT01327495

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

A Phase 2/3 study testing Testosterone 1% gel 1.25 g, Testosterone 1% gel 2.5 g and Testosterone 1% gel 5.0 g in people with Healthy, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 25 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Testosterone 1% gel 1.25 g, Testosterone 1% gel 2.5 g and Testosterone 1% gel 5.0 g
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Dec 2014
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)

Read the 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.

Conditions: Healthy
Being tested: placebo acyline, placebo gel, Testosterone 1% gel 1.25 g, Testosterone 1% gel 2.5 g, Testosterone 1% gel 5.0 g
Keywords: Androgen replacement in men

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placebo acylineOther
Also called placebo
Placebo acyline subcutaneous injection every 2 weeks
placebo gelOther
Also called placebo
daily placebo testosterone gel applied transdermally x 12 weeks
Testosterone 1% gel 1.25 gDrug
Also called Androgel
testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
Testosterone 1% gel 2.5 gDrug
Also called Androgel
Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
Testosterone 1% gel 5.0 gDrug
Also called Androgel
Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
testosterone 1% gel 10 gDrug
Also called Androgel
Testosterone 1% gel 10 g daily applied transdermally x 12 weeks
testosterone 1% gel 15 gDrug
Also called Androgel
Testosterone 1% gel 15 g daily applied transdermally x 12 weeks
AcylineDrug
Also called GNRH antagonist
300 ug/kg subcutaneous injection every 2 weeks

Study groups in NCT01327495
Study group	Role	What they receive
Arm 1: Placebo	Placebo comparator	Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks Receives: Other: placebo acyline; Other: placebo gel
Arm 2:1.25g Testosterone	Active comparator	Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks Receives: Drug: Testosterone 1% gel 1.25 g; Drug: Acyline
Arm 3: 2.5g Testosterone	Active comparator	Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks Receives: Drug: Testosterone 1% gel 2.5 g; Drug: Acyline
Arm 4: 5g Testosterone	Active comparator	Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks Receives: Drug: Testosterone 1% gel 5.0 g; Drug: Acyline
Arm 5: 10g Testosterone	Active comparator	Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks Receives: Drug: testosterone 1% gel 10 g; Drug: Acyline
Arm 6: 15g Testosterone	Active comparator	Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks Receives: Drug: testosterone 1% gel 15 g; Drug: Acyline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Prostate Specific Antigen
Measured: 12 weeks
Prostate Volume
Measured: 12 weeks
International Prostate Symptom Score (IPSS)
IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Dec 2014

First posted1 Apr 2011 (estimated)
Study startOct 2011
Primary completionJun 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327495
Sponsor's protocol ID: 39738
Other IDs: 1R01AG037603-01
Acronym: PROS-2
Status last verified: Sep 2017
First submitted: 21 Mar 2011
Last updated: 5 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 27172434

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)
ClinicalTrials.gov ID: NCT01327495
Acronym / sponsor ID: PROS-2 / 39738
Conditions: Healthy
Keywords: Androgen replacement in men
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Aging (NIA)
Study start: Oct 2011 (actual)
Primary completion: Jun 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 1 Apr 2011 (estimated)
Results: Posted 5 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Arm 1: Placebo	Placebo comparator	Other: placebo acyline, Other: placebo gelPlacebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks
Arm 2:1.25g Testosterone	Active comparator	Drug: Testosterone 1% gel 1.25 g, Drug: AcylineAcyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks
Arm 3: 2.5g Testosterone	Active comparator	Drug: Testosterone 1% gel 2.5 g, Drug: AcylineAcyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks
Arm 4: 5g Testosterone	Active comparator	Drug: Testosterone 1% gel 5.0 g, Drug: AcylineAcyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks
Arm 5: 10g Testosterone	Active comparator	Drug: testosterone 1% gel 10 g, Drug: AcylineAcyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks
Arm 6: 15g Testosterone	Active comparator	Drug: testosterone 1% gel 15 g, Drug: AcylineAcyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks

Who may qualify

Ages: 25 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebo acylineAlso: placeboPlacebo acyline subcutaneous injection every 2 weeks	Other	Arm 1: Placebo
placebo gelAlso: placebodaily placebo testosterone gel applied transdermally x 12 weeks	Other	Arm 1: Placebo
Testosterone 1% gel 1.25 gAlso: Androgeltestosterone 1% gel 1.25 g daily applied transdermally x 12 weeks	Drug	Arm 2:1.25g Testosterone
Testosterone 1% gel 2.5 gAlso: AndrogelTestosterone 1% gel 2.5 g daily applied transdermally x 12 weeks	Drug	Arm 3: 2.5g Testosterone
Testosterone 1% gel 5.0 gAlso: AndrogelTestosterone 1% gel 5.0 g daily applied transdermally x 12 weeks	Drug	Arm 4: 5g Testosterone
testosterone 1% gel 10 gAlso: AndrogelTestosterone 1% gel 10 g daily applied transdermally x 12 weeks	Drug	Arm 5: 10g Testosterone
testosterone 1% gel 15 gAlso: AndrogelTestosterone 1% gel 15 g daily applied transdermally x 12 weeks	Drug	Arm 6: 15g Testosterone
AcylineAlso: GNRH antagonist300 ug/kg subcutaneous injection every 2 weeks	Drug	Arm 2:1.25g Testosterone, Arm 3: 2.5g Testosterone, Arm 4: 5g Testosterone, Arm 5: 10g Testosterone, Arm 6: 15g Testosterone

Primary outcome

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

3 secondary outcomes

Prostate Specific Antigen
Time frame: 12 weeks
Prostate Volume
Time frame: 12 weeks
International Prostate Symptom Score (IPSS)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 5 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 (Placebo Acyline & Placebo T Gel )	10	8
Arm 2 (Acyline & 1.25g Testosterone Gel)	11	9
Arm 3 (Acyline & 2.5g Testosterone Gel)	10	8
Arm 4 (Acyline & 5g Testosterone Gel)	9	9
Arm 5 (Acyline & 10g Testosterone Gel)	11	8
Arm 6 (Acyline & 15g Testosterone Gel)	11	9

Primary outcome: Prostate Tissue DHT Concentrations After Treatment

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: ng/g

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n = 8	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n = 9	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n = 9	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n = 9
Value	4.05 (3.75 to 4.62)	4.26 (2.7 to 5.57)	2.99 (2.57 to 3.79)	3.88 (3.61 to 4.476)	4.12 (2.04 to 6.30)	5.11 (4.4 to 8.69)

Primary outcome: Serum Testosterone

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n = 8	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n = 9	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n = 9	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n = 9
Value	4.6 (3.1 to 5.0)	1.9 (1.3 to 3.8)	3.4 (2.5 to 4.4)	3.5 (2.9 to 6.4)	6.1 (2.7 to 9.9)	7.7 (5.3 to 10.9)

Primary outcome: Dihydrotestosterone (DHT)

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n = 8	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n = 9	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n = 9	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n = 9
Value	0.3 (0.3 to 0.5)	0.6 (0.3 to 0.7)	0.9 (0.5 to 1.2)	1.0 (0.7 to 1.2)	1.5 (0.6 to 2.5)	1.8 (1.0 to 3.6)

Primary outcome: Prostate Tissue Testosterone Concentrations After Treatment

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: ng/g

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n = 8	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n = 9	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n = 9	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n = 8	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n = 9
Value	0.3 (0.2275 to 0.535)	0.13 (0.11 to 0.24)	0.125 (0.1075 to 0.165)	0.18 (0.15 to 0.35)	0.195 (0.1275 to 0.77)	0.3 (0.22 to 1.72)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 10 (0%)	7 of 10 (70%)	Not reported
Arm 2	0 of 11 (0%)	8 of 11 (72.7%)	Not reported
Arm 3	0 of 10 (0%)	6 of 10 (60%)	Not reported
Arm 4	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
Arm 5	0 of 11 (0%)	10 of 11 (90.9%)	Not reported
Arm 6	0 of 11 (0%)	6 of 11 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27172434Thirumalai 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie T Page, MD, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Testosterone 1% gel 1.25 g, Testosterone 1% gel 2.5 g and Testosterone 1% gel 5.0 g in people with Healthy, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate Tissue DHT Concentrations After Treatment (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327495, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.