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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
Recruitment hospital [3] 0 0
- Footscray
Recruitment hospital [4] 0 0
- Frankston
Recruitment hospital [5] 0 0
- Garran
Recruitment hospital [6] 0 0
- Geelong
Recruitment hospital [7] 0 0
- Heidelberg
Recruitment hospital [8] 0 0
- Herston
Recruitment hospital [9] 0 0
- Hornsby
Recruitment hospital [10] 0 0
- Kogarah
Recruitment hospital [11] 0 0
- Kurralta Park
Recruitment hospital [12] 0 0
- Lismore
Recruitment hospital [13] 0 0
- Liverpool
Recruitment hospital [14] 0 0
- Malvern
Recruitment hospital [15] 0 0
- Parkville
Recruitment hospital [16] 0 0
- Perth
Recruitment hospital [17] 0 0
- South Brisbane
Recruitment hospital [18] 0 0
- Southport
Recruitment hospital [19] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Footscray
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Garran
Recruitment postcode(s) [6] 0 0
- Geelong
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
- Herston
Recruitment postcode(s) [9] 0 0
- Hornsby
Recruitment postcode(s) [10] 0 0
- Kogarah
Recruitment postcode(s) [11] 0 0
- Kurralta Park
Recruitment postcode(s) [12] 0 0
- Lismore
Recruitment postcode(s) [13] 0 0
- Liverpool
Recruitment postcode(s) [14] 0 0
- Malvern
Recruitment postcode(s) [15] 0 0
- Parkville
Recruitment postcode(s) [16] 0 0
- 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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State/province [3] 0 0
California
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United States of America
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Colorado
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Connecticut
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Florida
Country [7] 0 0
United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
State/province [9] 0 0
Kansas
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United States of America
State/province [10] 0 0
Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Wisconsin
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Belgium
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Aalst
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Antwerpen
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Gent
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Hasselt
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Clichy
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Hannover
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Homburg
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Kempen
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Leipzig
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Muenchen
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Münster
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Wuppertal
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Greece
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Larisa
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Amsterdam
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Heerlen
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Oviedo
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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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Stockholm
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Uppsala
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Växjö
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Birmingham
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Cambridge
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Glasgow
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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
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United Kingdom
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Wirral

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

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/NCT00887198