Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
Recruiting now · Phase 4
Conditions studied: Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
In brief
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.
Key facts
- Study ID
- NCT06733350
- Run by
- Roswell Park Cancer Institute
- People needed
- 600
- Starts
- 2025-01-15
- Expected to finish
- 2029-01-15
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men aged ≥ 18 years
- Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network [NCCN] very low, low, and intermediate favorable risk group)
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
You may not qualify if…
- Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
- For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,
- Locally advanced or metastatic prostate cancer
- Male breast cancer
- Men with an active desire to have children
- Hematocrit levels > 54% or baseline hematocrit of 48-50%
- Uncontrolled or poorly controlled congestive heart failure
- IPSS (International Prostate Symptom Score) score > 19
- Family history of venous thromboembolism
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.