Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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
3 other identifiers
interventional
1,088
11 countries
134
Brief Summary
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Apr 2009
Typical duration for phase_3 prostate-cancer
134 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
April 18, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Start
First participant enrolled
April 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2014
CompletedResults Posted
Study results publicly available
April 9, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2017
CompletedFebruary 4, 2025
January 1, 2025
4.9 years
April 18, 2009
March 30, 2015
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival is defined as the time from randomization to date of death from any cause.
From randomization (Day 1) up to end of study (Month 60)
Radiographic Progression-free Survival (rPFS)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Secondary Outcomes (9)
Time to Opiate Use for Prostate Cancer Pain
From randomization (Day 1) up to first opiate use or end of study (Month 60)
Time to Initiation of Cytotoxic Chemotherapy
From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Time to Prostate-specific Antigen (PSA) Progression
From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
Number of Participants With Treatment Emergent Adverse Events
From first dose of study drug up to 30 days after the last dose of study drug
- +4 more secondary outcomes
Study Arms (2)
Placebo + prednisone
PLACEBO COMPARATORPlacebo plus prednisone
Abiraterone + prednisone
EXPERIMENTALAbiraterone acetate plus prednisone
Interventions
Eligibility Criteria
You may qualify if:
- Metastatic castration-resistant prostate cancer (CRPC)
- Previous anti-androgen therapy and progression after withdrawal
- ECOG performance status of either 0 or 1
- Medical or surgical castration with testosterone less than 50 ng/dL
- Life expectancy of at least 6 months
You may not qualify if:
- Prior cytotoxic chemotherapy or biologic therapy for CRPC
- Prior ketoconazole for prostate cancer
- Known brain metastasis or visceral organ metastasis
- Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
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Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Bellflower, 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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Stanford, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Boca Raton, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Kansas City, Kansas, United States
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Metairie, 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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Dearborn, Michigan, United States
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Saint Louis Park, 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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East Syracuse, 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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Syracuse, 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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Cleveland, 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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Columbia, South Carolina, 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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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Adelaide, Australia
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Camperdown, Australia
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Footscray, Australia
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Frankston, Australia
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Garran, Australia
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Geelong, Australia
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Heidelberg, Australia
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Herston, Australia
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Hornsby, Australia
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Kogarah, Australia
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Kurralta Park, Australia
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Lismore, Australia
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Liverpool, Australia
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Malvern, Australia
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Parkville, Australia
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Perth, Australia
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South Brisbane, Australia
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Southport, Australia
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Subiaco, Australia
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Aalst, Belgium
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Antwerp, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Roeselare, Belgium
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Calgary, Alberta, Canada
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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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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Caen, France
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Clichy, France
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Dijon, France
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La Roche-sur-Yon, France
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Lyon, France
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Montpellier, France
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Paris, France
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Tours, France
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Villejuif, France
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Aachen, Germany
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Berlin, Germany
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Braunschweig, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Hamburg, Germany
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Hanover, Germany
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Homburg, Germany
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Kempen, Germany
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Leipzig, Germany
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München, Germany
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Münster, Germany
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Wuppertal, Germany
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Athens, Greece
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Larissa, Greece
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Amsterdam, Netherlands
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Heerlen, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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A Coruña, Spain
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Barcelona, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Oviedo, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Vaxjo, Sweden
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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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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Newcastle upon Tyne, 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 (13)
Lorente D, Llacer C, Lozano R, de Velasco G, Romero-Laorden N, Rodrigo M, Sanchez-Iglesias A, di Capua C, Castro E, Ferrer C, Sanchez-Hernandez A, Olmos D. Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer. Eur Urol. 2021 Nov;80(5):641-649. doi: 10.1016/j.eururo.2021.07.014. Epub 2021 Aug 6.
PMID: 34373138DERIVEDMiller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20.
PMID: 28939004DERIVEDde Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9.
PMID: 27402060DERIVEDFizazi 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: 26609008DERIVEDSaad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naive metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16.
PMID: 25985882DERIVEDXu 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: 25829400DERIVEDMorris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26.
PMID: 25624432DERIVEDRyan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.
PMID: 25601341DERIVEDAttard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15.
PMID: 25593303DERIVEDAggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.
PMID: 24787968DERIVEDRathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.
PMID: 24647231DERIVEDBasch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25.
PMID: 24075621DERIVEDRyan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.
PMID: 23228172DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SENIOR DIRECTOR CLINICAL RESEARCH
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
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
April 18, 2009
First Posted
April 23, 2009
Study Start
April 28, 2009
Primary Completion
March 31, 2014
Study Completion
May 25, 2017
Last Updated
February 4, 2025
Results First Posted
April 9, 2015
Record last verified: 2025-01