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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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, 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 * 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 * Uncontrolled cardiovascular disease and sleep apnea * 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
Study sites (2)
FL
- Desai Sethi Urology Institute · Miami, FL 33136Thomas Masterson · Principal investigatorMore trials in Miami
- Sylvester Comprehensive Cancer Center · Miami, FL 33136Thomas Masterson · Principal investigatorMore trials in Miami