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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00638690




Registration number
NCT00638690
Ethics application status
Date submitted
13/03/2008
Date registered
19/03/2008
Date last updated
30/04/2014

Titles & IDs
Public title
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Scientific 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
Secondary ID [1] 0 0
COU-AA-301
Secondary ID [2] 0 0
CR016924
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Abiraterone acetate plus prednisone/prednisolone -

Placebo comparator: Placebo plus prednisone/prednisolone -


Treatment: Drugs: Placebo
Four tablets once daily until disease progression

Treatment: Drugs: Abiraterone acetate
Four 250-mg tablets once daily until disease progression

Treatment: Drugs: Prednisone/prednisolone
5 mg twice daily until disease progression
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [1] 0 0
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Radiographic Progression-free Survival
Timepoint [3] 0 0
Up to 11 months

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

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
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
1195
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Footscray
Recruitment hospital [4] 0 0
- Geelong
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Herston
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- Hornsby
Recruitment hospital [9] 0 0
- Kogarah
Recruitment hospital [10] 0 0
- Kurralta Park
Recruitment hospital [11] 0 0
- Liverpool
Recruitment hospital [12] 0 0
- Milton
Recruitment hospital [13] 0 0
- Parkville
Recruitment hospital [14] 0 0
- Perth
Recruitment hospital [15] 0 0
- Subiaco
Recruitment hospital [16] 0 0
- Wodonga
Recruitment hospital [17] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Footscray
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- Geelong
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- Heidelberg
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- Herston
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- Hobart
Recruitment postcode(s) [8] 0 0
- Hornsby
Recruitment postcode(s) [9] 0 0
- Kogarah
Recruitment postcode(s) [10] 0 0
- Kurralta Park
Recruitment postcode(s) [11] 0 0
- Liverpool
Recruitment postcode(s) [12] 0 0
- Milton
Recruitment postcode(s) [13] 0 0
- Parkville
Recruitment postcode(s) [14] 0 0
- Perth
Recruitment postcode(s) [15] 0 0
- Subiaco
Recruitment postcode(s) [16] 0 0
- Wodonga
Recruitment postcode(s) [17] 0 0
- Wollongong
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Oregon
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Texas
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Virginia
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Washington
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Austria
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Linz
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Salzburg
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Wien
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Antwerpen
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Villejuif N/A
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Aachen
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Dresden
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Hamburg
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Germany
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Homburg/Saar
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Hungary
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Pecs
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Hungary
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Szombathely
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Cork
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Dublin 7
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Dublin
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Netherlands
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Nijmegen
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Badalona
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Barcelona
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Madrid
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Belfast
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Birmingham
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Cambridge
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Glasgow
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London
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Manchester
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Newcastle Upon Tyne
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Northwood
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Oxford
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Sutton
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United Kingdom
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Whitchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cougar Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cougar Biotechnology, Inc Clinical Trial
Address 0 0
Cougar Biotechnology, Inc.
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00638690