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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT06888102
Eligibility Criteria:
Inclusion Criteria
* Men electing to undergo radical prostatectomy with preoperative tissue available.
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate organ function defined by:
* AST and ALT \< 2.5 x ULN
* Total bilirubin \< 1.5 x ULN
* Platelets \> 90 x 1000/μL
* Hemoglobin (Hgb) \> 8.5 g/dL
* Serum Creatinine (Cr) \<1.5 x ULN or eGFR \> 30 mL/min
* People with partners of childbearing potential in circumstances that may result in the pregnancy, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception (latex or synthetic condom during sexual contact with a female of childbearing potential) from the start of study treatment until 3 months following last dose of study intervention. Subjects should not donate sperm on study, during interruptions in treatment and for 3 months following completion of study drug treatment.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria
* Active intercurrent illness or malignancy requiring therapy outside of prostate cancer.
* Other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)
* Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of epigenetic therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06888102
Study Brief:
Protocol Section:
NCT06888102