Metastatic Hormone-Naive Prostate Cancer (mHNPC) MedDRA version: 19.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology 2. Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging scan 3. At least two of the following high-risk prognostic factors: Gleason score of >=8; presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI scan based on RECIST 1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 5. Adequate hematologic, hepatic, and renal function 6. Agrees to protocol-defined use of effective contraception Treatment Criteria for Crossover to the Open-Label Extention Phase: 1. Subject is receiving study drug and is willing and able to provide written informed consent to crossover to open-label abiraterone acetate plus prednisone therapy 2. Adequatehepatic and safety laboratory assessment below within 4 weeks of OLE Phase Cycle 1 Day 1: - total bilirubin = 3.5 mM. If a subject has a serum potassum level= mM after adequate treatment with a potassum supplement, the subject would be eligible for enrollment in the OLE Phase Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 950
Exclusion criteria
Exclusion criteria: 1. Active infection or other medical condition that would make prednisone use contraindicated 2. Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day 3. Pathological finding consistent with small cell carcinoma of the prostate 4. Known brain metastasis 5. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer; the following exceptions are permitted: up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or orchiectomy with or without concurrent anti-androgens prior to Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1, all adverse events associated with these procedures must be resolved at least to Grade 1 by Cycle 1 Day 1. 6. Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic BP >=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment) 7. Active or symptomatic viral hepatitis or chronic liver disease, ascites or bleeding disorders secondary to hepatic dysfunction. 8. History of adrenal dysfunction 9. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events or history of cardiac failure in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease 10. Atrial fibrillation, or other cardiac arrhythmia requiring pharmacotherapy 11. Other malignancy (within 5 years), except non-melanoma skin cancer 12. Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 28 days of Cycle 1 Day 1 or currently enrolled in an investigational study 13. Any condition or situation which, in the opinion of the investigator, would put the patient at risk, may confound study results, or interfere with the patient’s participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether abiraterone acetate in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.;Secondary Objective: •To evaluate the clinically relevant improvements as well as the safety of abiraterone acetate plus low-dose prednisone and ADT compared to ADT alone. •To identify microRNA (miRNA) and mRNA profiles predictive of abiraterone acetate response or resistance. ;Primary end point(s): 1) Overall survival 2) Radiographic progression-free survival (PFS);Timepoint(s) of evaluation of this end point: 1) Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to Month 60 ( 5 years) 2) Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to Month 60 ( 5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Time to next subsequent therapy for prostate cancer 2) Time to initiation of chemotherapy 3) Time to prostate specific antigen progression 4) Time to next skeletal-related event 5) Time to pain progression;Timepoint(s) of evaluation of this end point: 1 & 2) From randomization to time to the occurrence of each event (up to Month 60) 3) Cycles 1-13 Day 1, Day 1 every other cycle starting Cycle 14 to end-of-treatment up to disease progression 4) From randomization to time to the occurrence of one of the following: clinical fracture, spinal cord compression, palliative radiation to bone, surgery to bone, up to Month 60 5) Up to Month 60 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Registry Group
Janseen-Cilag International NV
Outcome results
None listed