Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT06733350
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06733350
Study Brief:
Protocol Section:
NCT06733350