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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
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 - 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.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% - A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Radiographic Progression-free Survival - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Footscray
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- Geelong
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- 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
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- Perth
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- Subiaco
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- Wodonga
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- Wollongong
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- Adelaide
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- Camperdown
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- Footscray
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- Geelong
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- Heidelberg
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- Herston
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- Hobart
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- Hornsby
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- Kogarah
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- Kurralta Park
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- Liverpool
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- Milton
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- Parkville
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- Perth
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- Subiaco
Recruitment postcode(s) [16] 0 0
- Wodonga
Recruitment postcode(s) [17] 0 0
- Wollongong
Recruitment outside Australia
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Alabama
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Arizona
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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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Nebraska
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Tennessee
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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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Austria
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Salzburg
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Wien
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Pecs
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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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Nijmegen
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Barcelona
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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
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 website
https://clinicaltrials.gov/show/NCT00638690
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

Summary results
Other publications