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 range
18 Years
Sex
MALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT