NCT07278362RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 30 Nov 2026
- Primary completion date
- 31 May 2031
- Lead sponsor
- University of Miami
- Diseases
- Prostate cancer
- NCT number
- NCT07278362
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 35
- From 30 Nov 2026 to the primary completion date, 31 May 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket
Other illness
- History of Testosterone Replacement Therapy (TRT) within the past year.
- Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy
- T3 or T4 disease
- Unstable angina
- 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
Age
- Males \<18 years old
Other
- Current use of TRT
- PSA \>10 ng/mL at baseline
- Hematocrit \> 51% at baseline
- Unable or unwilling to provide informed consent or comply with study requirements
Who the study is looking for
- 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
- Males diagnosed with low-risk prostate cancer on active surveillance
- Two confirmatory testosterone levels \<350 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sylvester Comprehensive Cancer Center* Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Desai Sethi Urology Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.