NCT07278362 Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
| NCT ID | NCT07278362 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Miami |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-11-30 |
| Primary Completion | 2031-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 35 participants in total. It began in 2026-11-30 with a primary completion date of 2031-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 * 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 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 * 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 * Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket * Unable or unwilling to provide informed consent or comply with study requirements
Contact & Investigator
Bruce Kava, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07278362 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07278362 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07278362 currently recruiting?
Yes, NCT07278362 is actively recruiting participants. Contact the research team at bkava@med.miami.edu for enrollment information.
Where is the NCT07278362 trial being conducted?
This trial is being conducted at Miami, United States, Miami, United States.
Who is sponsoring the NCT07278362 clinical trial?
NCT07278362 is sponsored by University of Miami. The principal investigator is Bruce Kava, MD at University of Miami. The trial plans to enroll 35 participants.
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