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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00887198




Registration number
NCT00887198
Ethics application status
Date submitted
18/04/2009
Date registered
23/04/2009
Date last updated
25/06/2018

Titles & IDs
Public title
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Scientific title
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
Secondary ID [1] 0 0
COU-AA-302
Secondary ID [2] 0 0
CR016927
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone

Placebo comparator: Placebo + prednisone - Placebo plus prednisone

Experimental: Abiraterone + prednisone - Abiraterone acetate plus prednisone


Treatment: Drugs: Abiraterone acetate
1000 mg per day (4 x 250-mg tablets) taken orally.

Treatment: Drugs: Placebo
4 placebo tablets per day taken orally.

Treatment: Drugs: Prednisone
5 mg tablet orally twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization (Day 1) up to end of study (Month 60)
Primary outcome [2] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [2] 0 0
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Secondary outcome [1] 0 0
Time to Opiate Use for Prostate Cancer Pain
Timepoint [1] 0 0
From randomization (Day 1) up to first opiate use or end of study (Month 60)
Secondary outcome [2] 0 0
Time to Initiation of Cytotoxic Chemotherapy
Timepoint [2] 0 0
From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
Secondary outcome [3] 0 0
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
Timepoint [3] 0 0
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Secondary outcome [4] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [4] 0 0
From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
Secondary outcome [5] 0 0
Number of Participants With Treatment Emergent Adverse Events
Timepoint [5] 0 0
From first dose of study drug up to 30 days after the last dose of study drug
Secondary outcome [6] 0 0
Mean Plasma Concentrations of Abiraterone
Timepoint [6] 0 0
Up to Cycle 5, Day 1
Secondary outcome [7] 0 0
Maximum Plasma Concentrations of Abiraterone
Timepoint [7] 0 0
Up to Cycle 5, Day 1
Secondary outcome [8] 0 0
Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])
Timepoint [8] 0 0
Up to Cycle 5, Day 1
Secondary outcome [9] 0 0
Elimination Half-Life (t1/2)
Timepoint [9] 0 0
Up to Cycle 5, Day 1

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2017
Sample size
Target
Accrual to date
Final
1088
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
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- Footscray
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- Frankston
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- Garran
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- Geelong
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- Heidelberg
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- Herston
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- Hornsby
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- Kogarah
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- Kurralta Park
Recruitment hospital [12] 0 0
- Lismore
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- Liverpool
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- Malvern
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- Parkville
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- Perth
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- South Brisbane
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- Southport
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- Subiaco
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Camperdown
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- Footscray
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- Frankston
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- Garran
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- Geelong
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- Heidelberg
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- Herston
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- Hornsby
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- Kogarah
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- Kurralta Park
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- Lismore
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- Liverpool
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- Malvern
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- Parkville
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- Perth
Recruitment postcode(s) [17] 0 0
- South Brisbane
Recruitment postcode(s) [18] 0 0
- Southport
Recruitment postcode(s) [19] 0 0
- Subiaco
Recruitment outside Australia
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Alabama
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Michigan
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Clichy
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La Roche Sur Yon
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Lyon Cedex 03
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Paris Cedex 15
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Hannover
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Homburg
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Kempen
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Germany
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Leipzig
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Germany
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Muenchen
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Germany
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Münster
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Germany
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Wuppertal
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Greece
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Athens
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Greece
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Larisa
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Netherlands
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Amsterdam
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Heerlen
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Netherlands
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Nijmegen
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Rotterdam
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Spain
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Barcelona
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Coruña
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Madrid
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Spain
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Oviedo
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Spain
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Santander N/A
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Spain
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Santiago De Compostela
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Sweden
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Göteborg
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Sweden
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Malmö N/A
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Sweden
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Stockholm
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Sweden
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Uppsala
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Sweden
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Växjö
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Birmingham
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Cambridge
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Glasgow
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Leeds
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London
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Manchester
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Newcastle Upon Tyne
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Oxford
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Sutton
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Whitchurch
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00887198
Trial related presentations / publications
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.
Miller 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.
de 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.
Fizazi 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.
Saad 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.
Xu 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.
Morris 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.
Ryan 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.
Attard 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.
Aggarwal 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.
Rathkopf 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.
Basch 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.
Ryan 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. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00887198