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

Starting soon · Phase 4

Conditions studied: Prostate Cancer, Hypogonadism, Male

In brief

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.

Key facts

Study ID

NCT07278362

Run by

University of Miami

People needed

35

Starts

2026-08-31

Expected to finish

2032-05-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Desai Sethi Urology Institute — Miami, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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