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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT04740034
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed prostatic adenocarcinoma.
* History of metastatic disease.
* Chemically or surgically castrate.
* Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
* Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate \[eGFR\] ≥ 50 mL/min, aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] ≤ 3 x upper limit of normal \[ULN\], hemoglobin \[Hgb\] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm\^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count \[ANC\] ≥ 1500 / mm\^3).
Exclusion Criteria:
* Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
* History of neuroendocrine differentiation in the subject's disease.
* Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
* Subject has clinically significant CNS pathology.
* Subject requires chronic immunosuppressive therapy.
* Subject has a history of major cardiac abnormalities.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04740034
Study Brief:
Protocol Section:
NCT04740034