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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT06193993
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma prostate
2. Age \>21 years
3. Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) (chemotherapy naïve and chemotherapy pre-treated patients) or metastatic hormone-sensitive prostate cancer (mHSPC)
4. For mCRPC patients, evidence of castration resistance is defined as disease progression despite a testosterone level \<50ng/dL (or surgical castration)
5. Progressive disease was defined as either
1. PSA progression according to Prostate Cancer Working Group (PCWG2) criteria15: PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 1 week apart
2. Radiographic progression according to RECIST 1.1 guidelines or
3. 2 or more new lesions on bone scan
6. Newly initiated on abiraterone acetate therapy
7. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2.
8. Adequate hematologic, hepatic, and renal function would include:
* hemoglobin ≥9.0 g/dL independent of transfusions
* neutrophils ≥1.5 x 109/L
* platelets ≥100 x 109/L
* total bilirubin ≤1.5× upper limit of normal (ULN) \[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10× ULN\]
* alanine (ALT) and aspartate (AST) aminotransferase ≤2.5X ULN
* serum creatinine \<1.5× ULN or calculated creatinine clearance ≥30 mL/min
* serum potassium ≥3.5 mmol/L
9. Ability to provide informed consent
Exclusion Criteria:
1. Patients with prior use of enzalutamide or other potent androgen pathway targeted therapies
2. Concurrent therapy with strong inhibitors or inducers of CYP3A4 due to concerning possible drug-drug interactions with abiraterone.
3. Concurrent therapy with strong inhibitors or inducers of OATP transporters (e.g., rifampicin, cyclosporine) due to concerning possible effects on CP-I and CP-III.
4. New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
5. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥95 mmHg). Subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
6. Patients who do not voluntarily consent to participate in the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT06193993
Study Brief:
Protocol Section:
NCT06193993