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Testosterone Replacement for Low-Risk Prostate Cancer and Low Testosterone

This study is looking at the safety of testosterone replacement therapy in men who have newly diagnosed, low-risk prostate cancer and also have low testosterone (hypogonadism). You might be able to join if you are a man aged 18 or older, have low-risk prostate cancer that is being actively watched (active surveillance), and have two confirmed testosterone levels below 300 ng/dL. Participants will self-inject 100mg of testosterone cypionate once a week for 12 months. The main goal is to see how many participants experience their cancer getting worse within 12 months of starting the testosterone treatment. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 35 men. The phase of the study is not specified.
What's involved
Participants will self-inject testosterone cypionate once a week for 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months after starting treatment.

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NCT07278362

Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Miami
~35 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Testosterone cypionate

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
Measured over 12 months

Conditions

Prostate Cancer
Hypogonadism, Male

Explore related trials

HypogonadismProstate Carcinoma

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Bruce Kava, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Bruce Kava, MD
[email protected]
305-243-6590
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT12 months

    Disease progression is defined as either (1) an increase in prostate cancer grade group on biopsy or (2) conversion from active surveillance to active treatment (e.g., surgery, radiation, or systemic therapy). The proportion of participants who meet either criterion within 12 months of initiating testosterone replacement therapy (TRT) will be reported.