A Study of Abirateron Acetat and Prednisone with Androgen Deprivation Therapy (ADT) compared to ADT Alone in men newly Diagnosed (within the previous 3 months) with High-Risk, Metastatic Prostate Cancer
- Conditions
- Metastatic Hormone-Naive Prostate Cancer (mHNPC)MedDRA version: 14.1Level: 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-CZ
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1199
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
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
3. Known brain metastasis
4. 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
5. 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)
6. Active or symptomatic viral hepatitis or chronic liver disease, ascites or bleeding disorders secondary to hepatic dysfunction
7. History of adrenal dysfunction
8. 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 or cardiac ejection fraction measurement of <50% at baseline
9. Atrial fibrillation, or other cardiac arrhythmia requiring pharmacotherapy
10. Other malignancy (within 5 years), except non-melanoma skin cancer
11. 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
12. 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>•To identify microRNA (miRNA) and mRNA profiles predictive of ZYTIGA response or resistance.<br>;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Randomization up to the time of death from any cause
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Radiographic progression-free survival<br>2) Time to next subsequent therapy for prostate cancer<br>3) Time to initiation of chemotherapy<br>4) Time to prostate specific antigen progression<br>5) Time to next skeletal-related event<br>;Timepoint(s) of evaluation of this end point: 1) From randomization, up to disease progression or death from any cause (up to Month 60)<br>2 & 3) From randomization to time to the occurrence of each event (up to Month 60)<br>4) Cycles 1-13 Day 1, Day 1 every other cycle starting cycle 14 to end-of-treatment up to disease progression<br>5) From randomization to time to the occurrence of one of the following: clinical fracture, spinal cord compression, palliative radiation to bone, surgery to bone