Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance

Launched by ROSWELL PARK CANCER INSTITUTE · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether testosterone replacement therapy (TRT) can help men with low testosterone levels who have localized prostate cancer and are being monitored closely without immediate treatment, a process known as active surveillance. Many men with prostate cancer experience symptoms like low sexual desire and erectile issues due to low testosterone, and this trial aims to see if increasing testosterone levels through TRT can improve their quality of life and treatment outcomes.

To participate, men must be at least 18 years old and have localized prostate cancer that is considered to be at a very low, low, or intermediate favorable risk level. However, those with more aggressive forms of prostate cancer or certain health conditions that could complicate TRT are not eligible. Participants will be closely monitored, and the study will assess how TRT affects their symptoms and overall well-being while they continue their active surveillance. It’s important to note that TRT has not been widely used in men with prostate cancer due to concerns about the cancer worsening, so this study seeks to provide valuable information in this area.

Gender

MALE

Eligibility criteria

• 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
• • 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 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