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

RecruitingPhase 4

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

Who can join

Ages 18 and older · Men

Full eligibility criteria
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
* Males diagnosed with low-risk prostate cancer on active surveillance
* Two confirmatory testosterone levels \<350 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
* Unstable angina
* 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

About the study

The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.

What is being tested

Sponsor: University of Miami · Participants: 35 · Started: Nov 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07278362

Locations in the U.S.

FloridaDesai Sethi Urology Institute, Miami
Sylvester Comprehensive Cancer Center, Miami

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.