Actively Recruiting
Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
Led by Roswell Park Cancer Institute · Updated on 2026-05-14
600
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.
CONDITIONS
Official Title
Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- Men with localized prostate cancer eligible for active surveillance (NCCN very low, low, and intermediate favorable risk groups)
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Patients with intermediate unfavorable, high risk, or very high-risk localized prostate cancer
- Contraindications to TRT including locally advanced or metastatic prostate cancer
- Male breast cancer
- Desire to have children
- Hematocrit levels above 54% or baseline between 48-50%
- Uncontrolled or poorly controlled congestive heart failure
- International Prostate Symptom Score (IPSS) greater than 19
- Family history of venous thromboembolism
- Unwillingness or inability to follow the study protocol
- Any condition making the participant unsuitable for the study according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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