A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC).
- Conditions
- prostate cancer10036958
- Registration Number
- NL-OMON44898
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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;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
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; patients 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>EFFICACY EVALUATIONS: with protocol amendment INT-2 dd 18 April 2014 the<br /><br>radiographic progression-free survival (rPFS) was added as a co-primary<br /><br>endpoint with overall survival (OS)<br /><br><br /><br>Efficacy Endpoints<br /><br><br /><br>Co-primary endpoint: rPFS and OS<br /><br><br /><br>Overall survival (OS) is defined as the time from randomization to date of<br /><br>death from any cause. Survival<br /><br>data will be collected throughout the Double-blind Treatment Phase and during<br /><br>the Follow-up Phase.<br /><br>Once a subject has completed the Double-blind Treatment Phase, OS follow-up<br /><br>will be performed every<br /><br>4 months for up to 60 months (5 years) or until subject death, lost to<br /><br>follow-up, withdrawal of consent, or<br /><br>study termination.<br /><br>rPFS is defined as the time from randomization to the occurence of radiographic<br /><br>progression or death from any cause.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: time to next skeletal related event, time to prostate specific<br /><br>antigen (PSA) progression, time to next subsequent therapy for prostate cancer,<br /><br>time to initiation of chemotherapy and time to pain progression.<br /><br><br /><br>Exploratory: PSA response rate, PRO measures (EQ-5D-5L [Euro-QoL], Brief Pain<br /><br>Inventory-Short<br /><br>Form [BPI-SF], Functional Assessment Cancer Therapy-Prostate [FACT-P], Brief<br /><br>Fatigue Inventory<br /><br>[BFI]), pain measures (time to pain progression), time to symptomatic local<br /><br>progression defined as<br /><br>occurrence of urethral obstruction or bladder outlet obstruction, and prostate<br /><br>cancer specific survival.</p><br>