Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
Recruiting · NCT06733350 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.
Who can take part
Inclusion criteria
- Men aged ≥ 18 years
- Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \[NCCN\] very low, low, and intermediate favorable risk group)
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Exclusion criteria
- Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
- For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,
- Locally advanced or metastatic prostate cancer
- Male breast cancer
- Men with an active desire to have children
- Hematocrit levels \> 54% or baseline hematocrit of 48-50%
- Uncontrolled or poorly controlled congestive heart failure
- IPSS (International Prostate Symptom Score) score \> 19
- Family history of venous thromboembolism
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study
Where it is running
1 location listed across 1 US state.
- Roswell Park Cancer Institute - Buffalo, New York, United States