Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT07278362
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Hypogonadism, Male
- Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Testosterone cypionate — DRUGParticipants will self-inject 100mg of testosterone cypionate once per week for 12 months
Study Details
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.
Key Dates
- Start date
- May 31, 2026
- Status verified
- Feb 2026
- Primary completion
- May 31, 2031
- Completion
- May 31, 2032
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Testosterone cypionateParticipants will self-inject 100mg of testosterone cypionate once per week for 12 months
Primary Outcome Measure
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT [ Time Frame: 12 months ]
Central Contacts
- Thomas Masterson, MD305-243-6260
- Laura Angulo Llanos305-243-4850
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Desai Sethi Urology Institute | Miami | Florida | 33136 | Thomas Masterson (PRINCIPAL_INVESTIGATOR) |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | Thomas Masterson (PRINCIPAL_INVESTIGATOR) |
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