Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
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| ClinicalTrials.gov Identifier: NCT00638690 |
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Recruitment Status :
Completed
First Posted : March 19, 2008
Results First Posted : May 16, 2013
Last Update Posted : April 30, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostatic Neoplasms | Drug: Placebo Drug: Abiraterone acetate Drug: Prednisone/prednisolone | Phase 3 |
Abiraterone acetate is a steroidal irreversible inhibitor of CYP17 (17α hydroxylase/C17, 20-lyase), blocking 2 important enzymatic activities in the synthesis of testosterone. The goal of this study is to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains docetaxel. All patients involved in the study will be randomized (assigned by chance) into one of two arms and will not know what study drug is being given to them. Study drug randomization allocation will be 2:1 (abiraterone acetate: placebo). The study will be conducted in the United States, Canada, Australia, and the EU. The study will consist of screening, treatment, and follow-up. In this study, patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until progression of clinical disease. Follow-up will continue until patient dies, is lost to follow-up, or withdraws informed consent. After providing written informed consent, patients will have screening procedures completed to determine eligibility. Safety evaluations at the screening procedure will include a physical examination, vital signs, and clinical blood laboratory tests, ECG, radiographs, urine tests, and recording of any adverse events including details of current prostate cancer symptoms. Patients will be asked 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.
Study medication, abiraterone acetate,is an oral (by mouth) medication to be administered as four (4) 250mg abiraterone acetate tablets or 4 placebo tablets to be taken at least one hour before or two hours after a meal anytime up to 10PM everyday. Prednisone will be administered as 5mg orally twice a day for both groups. Each cycle will be 28 days. Study treatment will continue until disease progression as determined by investigator or when the patient meets criteria for withdrawal from study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1195 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | August 2010 |
| Actual Study Completion Date : | October 2012 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Abiraterone acetate plus prednisone/prednisolone |
Drug: Abiraterone acetate
Four 250-mg tablets once daily until disease progression Drug: Prednisone/prednisolone 5 mg twice daily until disease progression |
| Placebo Comparator: Placebo plus prednisone/prednisolone |
Drug: Placebo
Four tablets once daily until disease progression Drug: Prednisone/prednisolone 5 mg twice daily until disease progression |
- Overall Survival [ Time Frame: Up to 60 months ]Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
- Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria [ Time Frame: Up to 12 months ]The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
- Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% [ Time Frame: Up to 12 months ]A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.
- Radiographic Progression-free Survival [ Time Frame: Up to 11 months ]Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
- Medical or surgical castration with testosterone < 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium >= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
Exclusion Criteria:
- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638690
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| Study Director: | Cougar Biotechnology, Inc Clinical Trial | Cougar Biotechnology, Inc. |
| Responsible Party: | Cougar Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00638690 |
| Other Study ID Numbers: |
CR016924 COU-AA-301 ( Other Identifier: Cougar Biotechnology, Inc ) |
| First Posted: | March 19, 2008 Key Record Dates |
| Results First Posted: | May 16, 2013 |
| Last Update Posted: | April 30, 2014 |
| Last Verified: | April 2014 |
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Metastatic Castration-Resistant Prostate Cancer CRPC Abiraterone Acetate CB7630 |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Prednisone Prednisolone Abiraterone Acetate |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Cytochrome P-450 Enzyme Inhibitors |