Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
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
2 other identifiers
interventional
1,195
11 countries
110
Brief Summary
This is a phase 3 study 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. At least one of the previous chemotherapies must have contained docetaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2008
Typical duration for phase_3
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
May 16, 2013
CompletedApril 30, 2014
April 1, 2014
2.3 years
March 13, 2008
August 23, 2011
April 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
Up to 60 months
Secondary Outcomes (3)
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
Up to 12 months
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
Up to 12 months
Radiographic Progression-free Survival
Up to 11 months
Study Arms (2)
Abiraterone acetate plus prednisone/prednisolone
EXPERIMENTALPlacebo plus prednisone/prednisolone
PLACEBO COMPARATORInterventions
Four 250-mg tablets once daily until disease progression
5 mg twice daily until disease progression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
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Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Duarte, California, United States
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Los Angeles, California, United States
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Marina del Rey, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Bristol, Connecticut, United States
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New Haven, Connecticut, United States
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Stamford, Connecticut, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Galesburg, Illinois, United States
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Indianapolis, Indiana, United States
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Westwood, Kansas, United States
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Wichita, Kansas, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Robbinsdale, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Box 302, New York, United States
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East Setauket, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Virgiania Beach, Virginia, United States
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Seattle, Washington, United States
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Adelaide, Australia
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Camperdown, Australia
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Footscray, Australia
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Geelong, Australia
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Heidelberg, Australia
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Herston, Australia
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Hobart, Australia
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Hornsby, Australia
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Kogarah, Australia
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Kurralta Park, Australia
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Liverpool, Australia
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Milton, Australia
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Parkville, Australia
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Perth, Australia
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Subiaco, Australia
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Wodonga, Australia
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Wollongong, Australia
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Antwerp, Belgium
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Bonheiden, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Calgary Ab, Canada
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London, Canada
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Angers, France
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Caen, France
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Cannes, France
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Dijon, France
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Lyon, France
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Paris, France
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Saint-Herblain, France
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Vandœuvre-lès-Nancy, France
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Villejuif, France
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Aachen, Germany
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Berlin, Germany
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Dresden, Germany
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Hamburg, Germany
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Homburg/Saar, Germany
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Pécs, Hungary
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Szombathely, Hungary
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Cork, Ireland
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Dublin, Ireland
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Nijmegen, Netherlands
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Badalona, Spain
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Barcelona, Spain
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Madrid, Spain
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Northwood, United Kingdom
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Oxford, United Kingdom
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Sutton, United Kingdom
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Whitchurch, United Kingdom
Related Publications (12)
Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
PMID: 29272162DERIVEDChi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18.
PMID: 26685010DERIVEDFizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.
PMID: 26609008DERIVEDAntoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.
PMID: 26278649DERIVEDXu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.
PMID: 25829400DERIVEDScher HI, Heller G, Molina A, Attard G, Danila DC, Jia X, Peng W, Sandhu SK, Olmos D, Riisnaes R, McCormack R, Burzykowski T, Kheoh T, Fleisher M, Buyse M, de Bono JS. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer. J Clin Oncol. 2015 Apr 20;33(12):1348-55. doi: 10.1200/JCO.2014.55.3487. Epub 2015 Mar 23.
PMID: 25800753DERIVEDMulders PF, Molina A, Marberger M, Saad F, Higano CS, Chi KN, Li J, Kheoh T, Haqq CM, Fizazi K. Efficacy and safety of abiraterone acetate in an elderly patient subgroup (aged 75 and older) with metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. Eur Urol. 2014 May;65(5):875-83. doi: 10.1016/j.eururo.2013.09.005. Epub 2013 Sep 20.
PMID: 24099659DERIVEDHarland S, Staffurth J, Molina A, Hao Y, Gagnon DD, Sternberg CN, Cella D, Fizazi K, Logothetis CJ, Kheoh T, Haqq CM, de Bono JS, Scher HI; COU-AA-301 Investigators. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer. 2013 Nov;49(17):3648-57. doi: 10.1016/j.ejca.2013.07.144. Epub 2013 Aug 22.
PMID: 23973186DERIVEDRyan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, Grant RP, de Bono JS, Scher HI. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol. 2013 Aug 1;31(22):2791-8. doi: 10.1200/JCO.2012.45.4595. Epub 2013 Jul 1.
PMID: 23816964DERIVEDLogothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. doi: 10.1016/S1470-2045(12)70473-4. Epub 2012 Nov 9.
PMID: 23142059DERIVEDFizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18.
PMID: 22995653DERIVEDde Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
PMID: 21612468DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Research
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Cougar Biotechnology, Inc Clinical Trial
Cougar Biotechnology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2008
First Posted
March 19, 2008
Study Start
May 1, 2008
Primary Completion
August 1, 2010
Study Completion
October 1, 2012
Last Updated
April 30, 2014
Results First Posted
May 16, 2013
Record last verified: 2014-04