Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00036556
Registration number
NCT00036556
Ethics application status
Date submitted
10/05/2002
Date registered
13/05/2002
Date last updated
15/08/2007
Titles & IDs
Public title
Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Query!
Scientific title
A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Query!
Secondary ID [1]
0
0
M00-244
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Every 12 weeks
Query!
Eligibility
Key inclusion criteria
* Have been diagnosed with prostate cancer.
* Have a rising PSA while on hormone therapy or following surgical castration.
Query!
Minimum age
19
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Have evidence of distant metastatic disease on screening bone scan or CT scan.
* Have received cytotoxic chemotherapy.
* Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2001
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
941
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Prince Of Wales Hospital - Randwick
Query!
Recruitment hospital [2]
0
0
Westmead Public Hospital - Westmead
Query!
Recruitment hospital [3]
0
0
Royal Brisbane Hospital - Herston
Query!
Recruitment hospital [4]
0
0
Repatriation General Hospital - Daws Park
Query!
Recruitment hospital [5]
0
0
Peter Maccallum Cancer Institute - East Melbourne
Query!
Recruitment hospital [6]
0
0
Bayside Urology - Mentone
Query!
Recruitment hospital [7]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment hospital [8]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
5041 - Daws Park
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3194 - Mentone
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [8]
0
0
QLD 4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Alaska
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arizona
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Arkansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
California
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Colorado
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Mississippi
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Missouri
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Montana
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nebraska
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nevada
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New Mexico
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New York
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Ohio
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oklahoma
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Oregon
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Pennsylvania
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Rhode Island
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Tennessee
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Texas
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Utah
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Vermont
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Virginia
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Washington
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Wisconsin
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Wyoming
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Mistelbach
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Wien
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Antwerpen
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Brugge
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Bruxelles
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Gent
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Hasselt
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Liege
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Turnhout
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Alberta
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
British Columbia
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Manitoba
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
New Brunswick
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Nova Scotia
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Ontario
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Quebec
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Saskatchewan
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Cedex 14
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Auxerre
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Creteil
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Paris
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Celle
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Essen
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Freiburg
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Hamburg
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Homburg / Saar
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Lübeck
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Mannheim
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Munchen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
ULM
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Wuppertal
Query!
Country [71]
0
0
Greece
Query!
State/province [71]
0
0
Athens
Query!
Country [72]
0
0
Greece
Query!
State/province [72]
0
0
Heraklion
Query!
Country [73]
0
0
Greece
Query!
State/province [73]
0
0
Thessaloniki
Query!
Country [74]
0
0
Ireland
Query!
State/province [74]
0
0
Dublin
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Bari
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Genoa
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Milan
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Padova
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Verona
Query!
Country [80]
0
0
Netherlands
Query!
State/province [80]
0
0
Amsterdam
Query!
Country [81]
0
0
Netherlands
Query!
State/province [81]
0
0
Arnhem
Query!
Country [82]
0
0
Netherlands
Query!
State/province [82]
0
0
Enschede
Query!
Country [83]
0
0
Netherlands
Query!
State/province [83]
0
0
Heerlen
Query!
Country [84]
0
0
Netherlands
Query!
State/province [84]
0
0
Rotterdam
Query!
Country [85]
0
0
New Zealand
Query!
State/province [85]
0
0
Christchurch
Query!
Country [86]
0
0
New Zealand
Query!
State/province [86]
0
0
Tauranga
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Bydgoszcz
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Gdansk
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Katowice
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Warszawa
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Wroclaw
Query!
Country [92]
0
0
South Africa
Query!
State/province [92]
0
0
3201
Query!
Country [93]
0
0
South Africa
Query!
State/province [93]
0
0
Cape Town
Query!
Country [94]
0
0
South Africa
Query!
State/province [94]
0
0
Durban
Query!
Country [95]
0
0
South Africa
Query!
State/province [95]
0
0
Parktown
Query!
Country [96]
0
0
South Africa
Query!
State/province [96]
0
0
Pietermaritzburg
Query!
Country [97]
0
0
South Africa
Query!
State/province [97]
0
0
Pretoria
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Alcira (Valencia)
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Barcelona
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Galdakao-Vizcaya
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
La Coruna
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Madrid
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Malaga
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Santander
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Valencia
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Gothenburg
Query!
Country [107]
0
0
Sweden
Query!
State/province [107]
0
0
Linkoping
Query!
Country [108]
0
0
Sweden
Query!
State/province [108]
0
0
Lund
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Malmo
Query!
Country [110]
0
0
Sweden
Query!
State/province [110]
0
0
Stockholm
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Uppsala
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
Devon
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Hertfordshire
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Middlesex
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Scotland
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Somerset
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Surrey
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
West Yorkshire
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
Wirral
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
Bristol
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
Cambridge
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Chichester
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Crewe
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Glasgow
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
London
Query!
Country [126]
0
0
United Kingdom
Query!
State/province [126]
0
0
Salford
Query!
Country [127]
0
0
United Kingdom
Query!
State/province [127]
0
0
Sheffield
Query!
Country [128]
0
0
United Kingdom
Query!
State/province [128]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Abbott
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00036556
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gary Gordon, M.D.
Query!
Address
0
0
Abbott
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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 not provided in
https://clinicaltrials.gov/study/NCT00036556
Download to PDF