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 @ 10:31 PM
Ignite Modification Date:
2025-12-24 @ 10:31 PM
NCT ID:
NCT01695135
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate except neuroendocrine carcinoma including small cell carcinoma
* Disease progressed on or after prior docetaxel-containing chemotherapy
* Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer, at least 1 of which contains docetaxel
* Documented prostate cancer progression as documented by prostate specific antigen progression according to Prostate Specific Antigen Working Group criteria or radiographic progression in soft tissue or bone
* Surgically or medically castrated, with serum testosterone level \<50 ng/dL (1.7 nmol/L)
* Eastern Cooperative Oncology Group performance status score of \<=2
* Protocol-defined laboratory values
* Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
* Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
* Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
* Pathological finding consistent with neuroendocrine carcinoma of prostate including small cell carcinoma
* Uncontrolled hypertension (systolic BP \>=160 mmHg or diastolic BP \>=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy)
* Active or symptomatic viral hepatitis or chronic liver disease, have a known infection with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus
* History of pituitary or adrenal dysfunction.
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of \<50% at baseline
* Atrial fibrillation, or other cardiac arrhythmia requiring therapy
* Other malignancy within past 3 years (except basal or nonmetastatic squamous cell carcinoma of the skin)
* Known brain metastasis
* Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer
* Prior therapy with ketoconazole for prostate cancer
* Surgery or local prostatic intervention within 30 days of the first dose
* Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1
* Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events grade of \<=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed)
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
* Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks (bicalutamide or nilutamide) prior to Cycle 1 Day 1
* Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4 weeks prior to Cycle 1 Day 1
* Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
* Has contraindications to the use of prednisone per local prescribing information
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01695135
Study Brief:
Protocol Section:
NCT01695135