Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Survei… (NCT07278362) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
United States35 participantsStarted 2026-05-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT