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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00887198
Ethics application status
Date submitted
18/04/2009
Date registered
22/04/2009
Date last updated
24/05/2018

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 - Overall survival is defined as the time from randomization to date of death from any cause.
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) - The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
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 - The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
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 - The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
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 - The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
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 - The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
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 - An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
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]) - The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Timepoint [8] 0 0
Up to Cycle 5, Day 1
Secondary outcome [9] 0 0
Elimination Half-Life (t1/2) - The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
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
Gender
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
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
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
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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
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
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Alabama
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United States of America
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Arizona
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California
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Hawaii
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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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Minnesota
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Missouri
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Nebraska
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New York
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Virginia
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Wisconsin
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Aalst
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Antwerpen
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Gent
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Hasselt
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Homburg
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Kempen
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Leipzig
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Muenchen
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Larisa
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Amsterdam
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Heerlen
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Nijmegen
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Coruña
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Madrid
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Oviedo
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Santander N/A
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Santiago De Compostela
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Göteborg
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Malmö N/A
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Stockholm
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Sweden
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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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Leeds
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London
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United Kingdom
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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
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/show/NCT00887198
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

Summary results
Other publications