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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT03565835
Eligibility Criteria:
Inclusion Criteria:
1. The patient must be able to provide study-specific informed consent prior to study entry
2. Age ≥ 18
3. ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
4. Pathologically proven diagnosis of prostate adenocarcinoma
5. Patients must have metastatic prostate cancer
6. Patients may have mCRPC or may have metastatic castration-sensitive disease.
7. Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
8. The patient and the investigator have decided that the next line of cancer therapy will be abiraterone plus prednisone and the initial dose of abiraterone will be 1000 mg daily. Or patients may already be on abiraterone with prednisone at a dose of 1000 mg daily along with a GnRH analogue.
9. Lab values meeting the following criteria
1. Total testosterone level of \<50 ng/dl
2. Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
3. Aspartate aminotransferase (AST) ≤ 3 X ULN
4. Alanine aminotransferase (ALT ) ≤ 3 X ULN
5. Absolute Neutrophil Count \> 1.5 K/mm3
6. Platelets \> 100 K/mm3
7. Hemoglobin ≥9.0 g/dL
8. calculated creatinine clearance ≥ 30 mL/min
Exclusion Criteria:
10. History of bilateral orchiectomy
11. History of hypopituitarism
12. For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure \>170 mm Hg or diastolic blood pressure \>100 mm Hg)
13. Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any unstable angina, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration
14. Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03565835
Study Brief:
Protocol Section:
NCT03565835