A Study of Abiraterone Acetate and Prednisone with Androgen Deprivation Therapy (ADT) compared to ADT Alone in men newly Diagnosed (within the previous 3 months) with High-Risk, Metastatic (spread of cancer cells from one part of the body to another) Hormone-naive Prostate Cancer
- Conditions
- Metastatic Hormone-Naive Prostate Cancer (mHNPC)MedDRA version: 19.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002940-26-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 1270
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 <3.5 mM, he could be given adequate potassium supplement and retested. Once the serum potassium level is =3.5 mM after adequate treatment with a potassium 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method