Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/NCT00036543




Registration number
NCT00036543
Ethics application status
Date submitted
10/05/2002
Date registered
13/05/2002
Date last updated
15/08/2006

Titles & IDs
Public title
A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
Secondary ID [1] 0 0
M00-211
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Diagnosis of prostate cancer.
* Rising PSA while on hormonal therapy or following surgical castration.
* Documented evidence of metastatic disease.
Minimum age
19 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

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?



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
1/05/2001
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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Clinic - Darlinghurst
Recruitment hospital [2] 0 0
Prince Of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Westmead Public Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [5] 0 0
Repatriation General Hospital - Daws Park
Recruitment hospital [6] 0 0
Peter Maccallum Cancer Institute - East Melbourne
Recruitment hospital [7] 0 0
Bayside Urology - Mentone
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Hollywood Specialist Centre - Nedlands
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5041 - Daws Park
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3194 - Mentone
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
QLD 4102 - Woolloongabba
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
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Vermont
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
United States of America
State/province [33] 0 0
Wyoming
Country [34] 0 0
Austria
State/province [34] 0 0
Innsbruck
Country [35] 0 0
Austria
State/province [35] 0 0
Linz
Country [36] 0 0
Austria
State/province [36] 0 0
Salzburg
Country [37] 0 0
Belgium
State/province [37] 0 0
Antwerpen
Country [38] 0 0
Belgium
State/province [38] 0 0
Brugge
Country [39] 0 0
Belgium
State/province [39] 0 0
Bruxelles
Country [40] 0 0
Belgium
State/province [40] 0 0
Gent
Country [41] 0 0
Belgium
State/province [41] 0 0
Hasselt
Country [42] 0 0
Belgium
State/province [42] 0 0
Liege
Country [43] 0 0
Belgium
State/province [43] 0 0
Turnhout
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Canada
State/province [45] 0 0
British Columbia
Country [46] 0 0
Canada
State/province [46] 0 0
Manitoba
Country [47] 0 0
Canada
State/province [47] 0 0
Nova Scotia
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
France
State/province [50] 0 0
Cedex
Country [51] 0 0
France
State/province [51] 0 0
Caen
Country [52] 0 0
France
State/province [52] 0 0
Creteil
Country [53] 0 0
France
State/province [53] 0 0
Kremlin Bicetre
Country [54] 0 0
France
State/province [54] 0 0
Paris
Country [55] 0 0
France
State/province [55] 0 0
Suresnes
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Celle
Country [58] 0 0
Germany
State/province [58] 0 0
Dresden
Country [59] 0 0
Germany
State/province [59] 0 0
Essen
Country [60] 0 0
Germany
State/province [60] 0 0
Freiburg
Country [61] 0 0
Germany
State/province [61] 0 0
Hamburg
Country [62] 0 0
Germany
State/province [62] 0 0
Homburg / Saar
Country [63] 0 0
Germany
State/province [63] 0 0
LuBECK
Country [64] 0 0
Germany
State/province [64] 0 0
Mannheim
Country [65] 0 0
Germany
State/province [65] 0 0
Munchen
Country [66] 0 0
Germany
State/province [66] 0 0
Munster
Country [67] 0 0
Germany
State/province [67] 0 0
Offenbach
Country [68] 0 0
Germany
State/province [68] 0 0
ULM
Country [69] 0 0
Germany
State/province [69] 0 0
Wuppertal
Country [70] 0 0
Greece
State/province [70] 0 0
Athens
Country [71] 0 0
Greece
State/province [71] 0 0
Heraklion
Country [72] 0 0
Greece
State/province [72] 0 0
Thessaloniki
Country [73] 0 0
Ireland
State/province [73] 0 0
Dublin
Country [74] 0 0
Italy
State/province [74] 0 0
Bari
Country [75] 0 0
Italy
State/province [75] 0 0
Genoa
Country [76] 0 0
Italy
State/province [76] 0 0
Milan
Country [77] 0 0
Italy
State/province [77] 0 0
Padova
Country [78] 0 0
Italy
State/province [78] 0 0
Verona
Country [79] 0 0
Netherlands
State/province [79] 0 0
Amsterdam
Country [80] 0 0
Netherlands
State/province [80] 0 0
Arnhem
Country [81] 0 0
Netherlands
State/province [81] 0 0
Enschede
Country [82] 0 0
Netherlands
State/province [82] 0 0
Heerlen
Country [83] 0 0
Netherlands
State/province [83] 0 0
Maastricht
Country [84] 0 0
Netherlands
State/province [84] 0 0
Rotterdam
Country [85] 0 0
Netherlands
State/province [85] 0 0
Utrecht
Country [86] 0 0
New Zealand
State/province [86] 0 0
Christchurch
Country [87] 0 0
New Zealand
State/province [87] 0 0
Tauranga
Country [88] 0 0
Poland
State/province [88] 0 0
Gdansk
Country [89] 0 0
Poland
State/province [89] 0 0
Katowice
Country [90] 0 0
Poland
State/province [90] 0 0
Warszawa
Country [91] 0 0
Poland
State/province [91] 0 0
Wroclaw
Country [92] 0 0
South Africa
State/province [92] 0 0
3201
Country [93] 0 0
South Africa
State/province [93] 0 0
Cape Town
Country [94] 0 0
South Africa
State/province [94] 0 0
Durban
Country [95] 0 0
South Africa
State/province [95] 0 0
Parktown
Country [96] 0 0
South Africa
State/province [96] 0 0
Pietermaritzburg
Country [97] 0 0
South Africa
State/province [97] 0 0
Pretoria
Country [98] 0 0
Spain
State/province [98] 0 0
Barcelona
Country [99] 0 0
Spain
State/province [99] 0 0
Galdakao-Vizcaya
Country [100] 0 0
Spain
State/province [100] 0 0
La Coruna
Country [101] 0 0
Spain
State/province [101] 0 0
Madrid
Country [102] 0 0
Spain
State/province [102] 0 0
Malaga
Country [103] 0 0
Spain
State/province [103] 0 0
Santander
Country [104] 0 0
Spain
State/province [104] 0 0
Valencia
Country [105] 0 0
Sweden
State/province [105] 0 0
Gothenburg
Country [106] 0 0
Sweden
State/province [106] 0 0
Helsingborg
Country [107] 0 0
Sweden
State/province [107] 0 0
Linkoping
Country [108] 0 0
Sweden
State/province [108] 0 0
Lund
Country [109] 0 0
Sweden
State/province [109] 0 0
Malmo
Country [110] 0 0
Sweden
State/province [110] 0 0
Orebro
Country [111] 0 0
Sweden
State/province [111] 0 0
Stockholm
Country [112] 0 0
Sweden
State/province [112] 0 0
Umea
Country [113] 0 0
Sweden
State/province [113] 0 0
Uppsala
Country [114] 0 0
Switzerland
State/province [114] 0 0
Aarau
Country [115] 0 0
Switzerland
State/province [115] 0 0
Bern
Country [116] 0 0
Switzerland
State/province [116] 0 0
Zürich
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Devon
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Hertfordshire
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Middlesex
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Scotland
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Somerset
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Surrey
Country [123] 0 0
United Kingdom
State/province [123] 0 0
West Yorkshire
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Wirral
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Aberdeen
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Birmingham
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Brighton
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Bristol
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Cambridge
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Chichester
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Crewe
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Glasgow
Country [133] 0 0
United Kingdom
State/province [133] 0 0
High Heaton
Country [134] 0 0
United Kingdom
State/province [134] 0 0
London
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Nottingham
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Plymouth
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Salford
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Sheffield
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.
Trial website
https://clinicaltrials.gov/study/NCT00036543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Darryl Sleep, M.D.
Address 0 0
Abbott
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/study/NCT00036543