A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer.
- Conditions
- Asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.MedDRA version: 14.1Level: LLTClassification code 10029101Term: Neoplasm urogenitalSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2008-008004-41-IT
- Lead Sponsor
- JANSSEN-CILAG INTERNATIONAL N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1000
Each patient must meet the following criteria to be enrolled in this study. 1. Willing and able to provide written informed consent 2. Written Authorization for Use and Release of Health and Research Study Information (US sites only) or Data Protection Consent (European sites only) has been obtained 3. Male aged 18 years and above 4. Histologically or cytologically confirmed adenocarcinoma of the prostate 5. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be ` 2 cm in diameter 6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria 7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic. 8. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study. 9. Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (` 4 weeks since last flutamide, ` 6 weeks since last bicalutamide or nilutamide). 10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 11. Hemoglobin ` 10.0 g/dL independent of transfusion 12. Platelet count `100,000/`?`¼L 13. Serum albumin ` 3.5 g/dL 14. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ` 60 mL/min (see Appendix 7) 15. Serum potassium ` 3.5 mmol/L 16. Liver function: i. Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert`s disease) ii. AST or ALT < 2.5 x ULN 17. Able to swallow the study drug whole as a tablet 18. Life expectancy of at least 6 months 19. Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500
Patients who meet any of the following criteria will be excluded from the study: 1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 2. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid. 3. Pathological finding consistent with small cell carcinoma of the prostate 4. Liver or visceral organ metastasis 5. Known brain metastasis 6. Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1 7. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC 8. Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1 9. Radiation or radionuclide therapy for treatment of metastatic CRPC 10. Previously treated with ketoconazole for prostate cancer for greater than 7 days 11. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1 12. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1) 13. Bicalutamide (Casodex), nilutamide (andron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1) 14. Uncontrolled hypertension (systolic BP ` 160 mmHg or diastolic BP ` 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 15. Active or symptomatic viral hepatitis or chronic liver disease 16. History of pituitary or adrenal dysfunction 17. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events 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 18. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy 19. Other malignancy, except non-melanoma skin cancer, with a ` 30% probability of recurrence within 24 months 20. Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1 21. Any condition which, in the opinion of the investigator, would preclude participation in this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naive castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic;Secondary Objective: To establish additional clinically relevant improvements in prostate cancer patients treated with abiraterone acetate in comparison to placebo. To characterize the safety profile of abiraterone acetate in this patient population. To characterize the pharmacokinetics of abiraterone acetate when administered concurrently with prednisone.;Primary end point(s): Co-primary efficacy endpoints: Overall survival (OS) and radiographic progression-free survival (rPFS).;Timepoint(s) of evaluation of this end point: At day 1 of cycles 3, 5, 7, 10, 13, 16, 19 etc...of treatment (each cycle being 28 days).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy assessments: time to opiate use for cancer-related pain and time to administration of cytoxic chemotherapy for metastatic prostate cancer will be prospectively assessed; EOCG performance status will be evaluated throughout the study to assess time to first deterioration; PSA values will be collected throughout the study to assess time to PSA progression;Timepoint(s) of evaluation of this end point: EOCG status - at day 1 of cycles 1, 2, 3, 4, 5, 6 etc...of treatment (each cycle being 28 days).