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Testosterone therapy under scrutiny in prostate cancer patients

NCT ID NCT07278362

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study looks at whether testosterone replacement therapy (TRT) is safe for men with low-risk prostate cancer who also have low testosterone. Researchers will monitor 35 men for 12 months to see if the cancer gets worse or if they need stronger treatment. The goal is to help manage symptoms of low testosterone without increasing cancer risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males aged ≥ 18 years old * Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI, and had a second confirmatory biopsy within the last 12 months * Males diagnosed with low-risk prostate cancer undergoing active surveillance * Two confirmatory testosterone levels \<300 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests * Symptoms of low testosterone (Aging Male's Symptoms Score \>27) * Able to obtain Testosterone medication through insurance or out-of-pocket * Willing and able to provide written informed consent and able to comply with study requirements Exclusion Criteria: * Males \<18 years old * History of Testosterone Replacement Therapy (TRT) within the past year. * Current use of TRT * Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy * PSA \>10 ng/mL at baseline * Hematocrit \> 51% at baseline * T3 or T4 disease * Uncontrolled cardiovascular disease and sleep apnea * History of breast cancer * Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation * Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket * Unable or unwilling to provide informed consent or comply with study requirements

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Conditions

The condition(s) this trial relates to.

eunuchism hypogonadism, male prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypogonadism, male Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Desai Sethi Urology Institute

    Miami, Florida, 33136, United States

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

More trials for these conditions

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