Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
4/02/2025

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
Assessment method [1] 0 0
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)
Assessment method [2] 0 0
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
Assessment method [1] 0 0
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
Assessment method [2] 0 0
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
Assessment method [3] 0 0
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
Assessment method [4] 0 0
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
Assessment method [5] 0 0
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
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to Cycle 5, Day 1
Secondary outcome [7] 0 0
Maximum Plasma Concentrations of Abiraterone
Assessment method [7] 0 0
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])
Assessment method [8] 0 0
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)
Assessment method [9] 0 0
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
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Belgium
State/province [30] 0 0
Aalst
Country [31] 0 0
Belgium
State/province [31] 0 0
Antwerpen
Country [32] 0 0
Belgium
State/province [32] 0 0
Gent
Country [33] 0 0
Belgium
State/province [33] 0 0
Hasselt
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Roeselare
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
France
State/province [40] 0 0
Caen
Country [41] 0 0
France
State/province [41] 0 0
Clichy
Country [42] 0 0
France
State/province [42] 0 0
Dijon Cedex
Country [43] 0 0
France
State/province [43] 0 0
La Roche sur Yon
Country [44] 0 0
France
State/province [44] 0 0
Lyon Cedex 03
Country [45] 0 0
France
State/province [45] 0 0
Lyon
Country [46] 0 0
France
State/province [46] 0 0
Montpellier
Country [47] 0 0
France
State/province [47] 0 0
Paris Cedex 15
Country [48] 0 0
France
State/province [48] 0 0
Tours
Country [49] 0 0
France
State/province [49] 0 0
Villejuif
Country [50] 0 0
Germany
State/province [50] 0 0
Aachen
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
Country [52] 0 0
Germany
State/province [52] 0 0
Braunschweig
Country [53] 0 0
Germany
State/province [53] 0 0
Dresden
Country [54] 0 0
Germany
State/province [54] 0 0
Düsseldorf
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
Country [56] 0 0
Germany
State/province [56] 0 0
Hannover
Country [57] 0 0
Germany
State/province [57] 0 0
Homburg
Country [58] 0 0
Germany
State/province [58] 0 0
Kempen
Country [59] 0 0
Germany
State/province [59] 0 0
Leipzig
Country [60] 0 0
Germany
State/province [60] 0 0
Muenchen
Country [61] 0 0
Germany
State/province [61] 0 0
Münster
Country [62] 0 0
Germany
State/province [62] 0 0
Wuppertal
Country [63] 0 0
Greece
State/province [63] 0 0
Athens
Country [64] 0 0
Greece
State/province [64] 0 0
Larisa
Country [65] 0 0
Netherlands
State/province [65] 0 0
Amsterdam
Country [66] 0 0
Netherlands
State/province [66] 0 0
Heerlen
Country [67] 0 0
Netherlands
State/province [67] 0 0
Nijmegen
Country [68] 0 0
Netherlands
State/province [68] 0 0
Rotterdam
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
State/province [70] 0 0
Coruña
Country [71] 0 0
Spain
State/province [71] 0 0
Hospitalet de Llobregat
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Oviedo
Country [74] 0 0
Spain
State/province [74] 0 0
Santander N/a
Country [75] 0 0
Spain
State/province [75] 0 0
Santiago De Compostela
Country [76] 0 0
Sweden
State/province [76] 0 0
Göteborg
Country [77] 0 0
Sweden
State/province [77] 0 0
Malmö N/a
Country [78] 0 0
Sweden
State/province [78] 0 0
Stockholm
Country [79] 0 0
Sweden
State/province [79] 0 0
Uppsala
Country [80] 0 0
Sweden
State/province [80] 0 0
Växjö
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Birmingham
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Cambridge
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Glasgow
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Leeds
Country [85] 0 0
United Kingdom
State/province [85] 0 0
London
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Manchester
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Newcastle Upon Tyne
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Oxford
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Sutton
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Whitchurch
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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