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 Extension 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. Adequate hepatic and safety laboratory assessments below within 4 weeks of OLE Phase Cycle 1 Day 1: • total bilirubin =1.5X upper limit of normal (ULN) (except for subjects with documented Gilbert’s disease in which case total bilirubin not to exceed 10X ULN) • alanine (ALT) and aspartate (AST) aminotransferase =2.5X ULN • serum potassium =3.5 mM. If a subject has a serum potassium level =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether abiraterone acetate in combination with low-dose prednisone and androgen deprivation therapy (ADT) is superior to ADT alone in improving rPFS and OS 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 in this patient population. ;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 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, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed