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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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)
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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
Recruitment hospital [10] 0 0
- Kurralta Park
Recruitment hospital [11] 0 0
- Liverpool
Recruitment hospital [12] 0 0
- Milton
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- 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
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- Wodonga
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- Wollongong
Recruitment outside Australia
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Linz
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Northwood
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Oxford
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Sutton
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00638690