Prostate Neoplasms
Conditions
Keywords
Prostate neoplasms, Prostate cancer, Castration resistant prostate cancer, Hormone refractory prostate cancer, Abiraterone acetate, Taxane
Brief summary
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.
Detailed description
This is an open-label (identity of assigned study drug will be known), observational study to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic CRPC who have received prior chemotherapy containing a taxane. Approximately 50 patients will be enrolled. Abiraterone acetate will be administered according to the approved product insert with a low-dose glucocorticoid (prednisone or prednisolone). Patient assessments will be based on the accepted clinical practice in the Philippines. Patients will be monitored for 40 weeks.
Interventions
DRUGAbiraterone acetate
Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
DRUGPrednisone
Prednisone or prednisolone 5 mg tablet taken orally twice daily
Sponsors
Janssen Pharmaceutica
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic castration resistant prostate cancer (CRPC) (at least 1 regimen must have contained a taxane such as docetaxel; if a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen) * Agrees to protocol-defined use of effective contraception * Laboratory values within protocol -defined parameters
Exclusion criteria
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Abnormal liver function * Uncontrolled hypertension (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg) * Active or symptomatic viral hepatitis or chronic liver disease * 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 (NYHA) Class III or IV heart disease or left ventricular ejection fraction of \<50% at baseline * Known brain metastasis * History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug * Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of \<=1 * Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1 * Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study * Participation in an investigational drug trial within 30 days prior to selection * Known hypersensitivity to abiraterone acetate, or to any of the components in the formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants affected by an adverse event | Up to 30 days after the last dose of study medication |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with disease progression | Baseline up to Week 40 |
Outcome results
None listed