Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Miami
About this trial
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
Qualifiers
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, and had a second confirmatory biopsy within the last 12 months
Males diagnosed with low-risk prostate cancer undergoing active surveillance
Two confirmatory testosterone levels <300 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests
Disqualifiers
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
Trial design
Treatments tested in this trial
- Testosterone cypionate
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov