A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

NCT ID: NCT00036543

Last Updated: 2006-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Brief Summary

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This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Hormone-Refractory, Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atrasentan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of prostate cancer.
* Rising PSA while on hormonal therapy or following surgical castration.
* Documented evidence of metastatic disease.

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.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Darryl Sleep, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Urology Centers Of Alabama

Homewood, Alabama, United States

Site Status

Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Site Status

Advanced Clinical Trials

Tucson, Arizona, United States

Site Status

Arkansas Urologial Associates, PA

Little Rock, Arkansas, United States

Site Status

Robin V. Smith, MD

Chula Vista, California, United States

Site Status

Urology Associate Of Central California

Fresno, California, United States

Site Status

South Valley Medical Plaza

Gilroy, California, United States

Site Status

San Diego Urology Center

La Mesa, California, United States

Site Status

UCLA School Of Medicine

Los Angeles, California, United States

Site Status

Hillcrest Urological Medical Group, Inc.

San Diego, California, United States

Site Status

Urology Associates Of San Luis Obispo

San Luis Obispo, California, United States

Site Status

Pacific Clinical Research

Santa Monica, California, United States

Site Status

Western Clinical Research, Inc.

Torrance, California, United States

Site Status

Urology Associate, Pc

Denver, Colorado, United States

Site Status

South Fl Medical Research

Aventura, Florida, United States

Site Status

Clinical Physiology Associates

Fort Myers, Florida, United States

Site Status

Advanced Research Institute

New Port Richey, Florida, United States

Site Status

Urology Treatment Center

Sarasota, Florida, United States

Site Status

Southeastern Urological Center, P.A.

Tallahassee, Florida, United States

Site Status

Winship Cancer Institute Emory University

Atlanta, Georgia, United States

Site Status

Sandy Springs Urology

Atlanta, Georgia, United States

Site Status

Atlanta Va Medical Center

Decatur, Georgia, United States

Site Status

Dreyer Medical Clinic

Aurora, Illinois, United States

Site Status

Progressive Care, S.C.

Chicago, Illinois, United States

Site Status

Weiss Memorial Hospital

Chicago, Illinois, United States

Site Status

Evanston Hospital Kellogg Cancer Center

Evanston, Illinois, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

Urologic Associates, Pc

Davenport, Iowa, United States

Site Status

Iowa Urology

Des Moines, Iowa, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Ochsner Clinic, Department of Urology

New Orleans, Louisiana, United States

Site Status

Regional Urology

Shreveport, Louisiana, United States

Site Status

LSUHSC

Shreveport, Louisiana, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

Mid Atlantic Clinical Research

Rockville, Maryland, United States

Site Status

Michigan Institute Of Urology, Pc

Saint Clair Shores, Michigan, United States

Site Status

Lakeside Urology, PC

Saint Joseph, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

The Medical Oncology Group

Gulfport, Mississippi, United States

Site Status

St. Joseph Oncology

Saint Joseph, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Billings Oncology Associates

Billings, Montana, United States

Site Status

Nevada Urology Associate

Reno, Nevada, United States

Site Status

Albany Medical Center South Clinical Campus

Albany, New York, United States

Site Status

HemOnCare, PC

Brooklyn, New York, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

NYU Medical Center

New York, New York, United States

Site Status

Nyack Hospital

Nyack, New York, United States

Site Status

Rochester General Hospital

Rochester, New York, United States

Site Status

St. Vincent's Medical Center - Staten Island

Staten Island, New York, United States

Site Status

Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

The University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Blumenthal Cancer Center

Charlotte, North Carolina, United States

Site Status

The Urology Center

Greensboro, North Carolina, United States

Site Status

Urologic Specialists Of Oklahoma, Inc.

Tulsa, Oklahoma, United States

Site Status

Oregon Urology Specialists

Eugene, Oregon, United States

Site Status

Urologic Associates of Allentown

Allentown, Pennsylvania, United States

Site Status

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Urological Associates Of Lancaster

Lancaster, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Center for Urologic Care

West Reading, Pennsylvania, United States

Site Status

Urology Associates

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Dept of Veteran's Affairs North Texas Healthcare System

Dallas, Texas, United States

Site Status

Ntouch Research Corporation

Dallas, Texas, United States

Site Status

Uthscsa

San Antonio, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Anthony Middleton, M.D.

Salt Lake City, Utah, United States

Site Status

Western Urological Clinic

Salt Lake City, Utah, United States

Site Status

University Of Vermont

Burlington, Vermont, United States

Site Status

Virginia Urology Center

Richmond, Virginia, United States

Site Status

Seattle Urological Associates

Seattle, Washington, United States

Site Status

University Of Washington School Of Medicine

Seattle, Washington, United States

Site Status

Jeffrey Frankel, M.D.

Seattle, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Midwest Research Specialists, LLC

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Wyoming Research Foundation

Cheyenne, Wyoming, United States

Site Status

St Vincent's Clinic

Darlinghurst, New South Wales, Australia

Site Status

Prince Of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Westmead Public Hospital

Westmead, New South Wales, Australia

Site Status

Royal Brisbane Hospital

Herston, Queensland, Australia

Site Status

Repatriation General Hospital

Daws Park, South Australia, Australia

Site Status

Peter Maccallum Cancer Institute

East Melbourne, Victoria, Australia

Site Status

Bayside Urology

Mentone, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Hollywood Specialist Centre

Nedlands, Western Australia, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, , Australia

Site Status

Universitatsklinik Innsbruck

Innsbruck, , Austria

Site Status

Urologische Abteilung

Linz, , Austria

Site Status

Landesklinik fur Urologie und Andrologie

Salzburg, , Austria

Site Status

A.Z. Middelheim

Antwerp, , Belgium

Site Status

AZ Middelheim

Antwerp, , Belgium

Site Status

A Z St Jan

Bruges, , Belgium

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University Hospital Erasme

Brussels, , Belgium

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Uz Gent

Ghent, , Belgium

Site Status

Virga Jesse Hospital

Hasselt, , Belgium

Site Status

C.H.U. Liege

Liège, , Belgium

Site Status

St-Elisabeth Ziekenhuis

Turnhout, , Belgium

Site Status

Tom Baker Cancer Center

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Wilson Urology

Kelowna, British Columbia, Canada

Site Status

Dr. Cal Andreou

Surrey, British Columbia, Canada

Site Status

Vancouver Hospital & Health Sciences Centre

Vancouver, British Columbia, Canada

Site Status

Dr. P. J. Pommerville, Inc.

Victoria, British Columbia, Canada

Site Status

Dr. Gary Steinhoff, Clinical Research

Victoria, British Columbia, Canada

Site Status

Abbott Clinic

Winnipeg, Manitoba, Canada

Site Status

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status

Valley Professional Centre

Kentville, Nova Scotia, Canada

Site Status

The Male Health Centres

Barrie, Ontario, Canada

Site Status

Burlington Professional Centre

Burlington, Ontario, Canada

Site Status

The Urology Resource Centre

Burlington, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Probidity Medical Research

Kitchener, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Quest Clinical Trials

Markham, Ontario, Canada

Site Status

Walk-In Clinic

North Bay, Ontario, Canada

Site Status

Jack Barkin, M.D.

North York, Ontario, Canada

Site Status

The Male Health Centres

Oakville, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Service Radio-Oncologie, Chus

Fleurimont, Quebec, Canada

Site Status

Hopital Notre-Dame

Montreal, Quebec, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Ultramed

Pointe-Claire, Quebec, Canada

Site Status

Chuq Pavillon Hotel-Dieu

Québec, Quebec, Canada

Site Status

Hopital De Pontchaillou

Rennes, Cedex, France

Site Status

Hopital De Rangueil

Toulouse, Cedex, France

Site Status

CHU Hôpital Côte De Nacre

Caen, , France

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Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Hopital Bichat Claude Bernard

Paris, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Krankenhaus Am Urban

Berlin, , Germany

Site Status

Allgemeines Krankenhaus Urologie

Celle, , Germany

Site Status

Universitätsklinikum Carl Gustav Carus an der

Dresden, , Germany

Site Status

Universitätsklinikum Urologie

Essen, , Germany

Site Status

Universitätsklinkum

Freiburg im Breisgau, , Germany

Site Status

Allgemeines Krankenhaus Barmbek

Hamburg, , Germany

Site Status

Klinik Und Poliklinik für Urologie und Kinder

Homburg / SAAR, , Germany

Site Status

Universitutsklinikum Lubeck Urologie

Lübeck, , Germany

Site Status

Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status

Urologische Klinik Und Poliklinik Grosshadern

München, , Germany

Site Status

Klinikum Rechts Der Isar

München, , Germany

Site Status

Universitätsklinikum

Münster, , Germany

Site Status

Städtische Kliniken, Urologie

Offenbach, , Germany

Site Status

Universitat Ulm

Ulm, , Germany

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Klinikum Wuppertal GmbH

Wuppertal, , Germany

Site Status

'Alexandra' Hospital

Athens, , Greece

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Pe.Pa.G.N.I Hospital

Heraklion, , Greece

Site Status

G. Genimatas Hospital

Thessaloniki, , Greece

Site Status

Tallaght Hospital

Dublin, , Ireland

Site Status

St Vincent'S Hospital

Dublin, , Ireland

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Mater Misericordiae Hospital

Dublin, , Ireland

Site Status

Clinica Urologica I - Università di Bari

Bari, , Italy

Site Status

Istituto Nazionale per la Ricerca sul Cancro -IST

Genoa, , Italy

Site Status

Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Clinica Urologica - Università Di Milano

Milan, , Italy

Site Status

Istituto di Urologia

Padua, , Italy

Site Status

Policlinico G. B. Rossi

Verona, , Italy

Site Status

Amc

Amsterdam, , Netherlands

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Rijnstate Hospital

Arnhem, , Netherlands

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Medisch Spectrun Twente

Enschede, , Netherlands

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Atrium Heerlen

Heerlen, , Netherlands

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University Hospital Maastricht

Maastricht, , Netherlands

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University Hospital Rotterdam

Rotterdam, , Netherlands

Site Status

St Franciscus Gasthuis

Rotterdam, , Netherlands

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University Hospital Utrecht

Utrecht, , Netherlands

Site Status

Canterbury Urology Research Trust

Christchurch, , New Zealand

Site Status

Promed Urology Ltd.

Tauranga, , New Zealand

Site Status

Katedra I Klinika Urologi AM

Gdansk, , Poland

Site Status

Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

Gdansk, , Poland

Site Status

Samodzielny Publiczny Zaklad Opieki

Katowice, , Poland

Site Status

Szpital Kliniczny Dzieciatka Jezus

Warsaw, , Poland

Site Status

Akademia Medyczna we Wroclawiu

Wroclaw, , Poland

Site Status

Mediclinic Hospital

Petermaritzburg, 3201, South Africa

Site Status

Constantiaberg Medi-Clinic

Cape Town, , South Africa

Site Status

University Of Stellenbosch

Cape Town, , South Africa

Site Status

University Of Natal - Nelson R Mandela School of Medicine

Durban, , South Africa

Site Status

Kenridge St Joseph Wingl

Parktown, , South Africa

Site Status

Medi-Clinic Hospital

Pietermaritzburg, , South Africa

Site Status

Medical Centre

Pietermaritzburg, , South Africa

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Pretoria Urology Hospital

Pretoria, , South Africa

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Pretoria Academic Hospital

Pretoria, , South Africa

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Hospital Juan Canalejo

A Coruña, , Spain

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Fundacion Puigvert

Barcelona, , Spain

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Hospital Vall D'Hebron

Barcelona, , Spain

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Hospital de Galdakao

Galdakao-Vizcaya, , Spain

Site Status

Hospital Gregorio Maranon

Madrid, , Spain

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Clinica Puerta De Hierro

Madrid, , Spain

Site Status

Hospital 12 De Octubre

Madrid, , Spain

Site Status

Hospital Carlos Haya

Málaga, , Spain

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Hospital Marques De Valdecilla

Santander, , Spain

Site Status

Instituto Valenciano De Oncologia

Valencia, , Spain

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Helsingborg Hospital

Helsingborg, , Sweden

Site Status

Linkoping University Hospital

Linköping, , Sweden

Site Status

Lund University Hospital

Lund, , Sweden

Site Status

Malmo University Hospital MAS

Malmo, , Sweden

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Orebro Regional Hospital

Örebro, , Sweden

Site Status

Karolinska Hospital

Stockholm, , Sweden

Site Status

Umea University Hospital

Umeå, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Zentrum fur Onkologie, Hämatologie und

Aarau, , Switzerland

Site Status

Inselspital, Universität Bern

Bern, , Switzerland

Site Status

Chefarzt Urologische Klinik - Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Royal Devon And Exeter Hospital

Exeter, Devon, United Kingdom

Site Status

Lister Hospital

Stevenage, Hertfordshire, United Kingdom

Site Status

Northwick Park Hospital

Harrow, Middlesex, United Kingdom

Site Status

Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status

Taunton And Somerset Hospital

Taunton, Somerset, United Kingdom

Site Status

The Institute Of Cancer Research - Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status

St Lukes Hospital

Bradford, West Yorkshire, United Kingdom

Site Status

Clatterbridge Centre For Oncology

Bebington, WIRRAL, United Kingdom

Site Status

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

Institute Of Cancer Studies - University of Birmingham

Birmingham, , United Kingdom

Site Status

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

Southmead Hospital

Bristol, , United Kingdom

Site Status

Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

St Richard'S Hospital

Chichester, , United Kingdom

Site Status

Leighton Hospital

Crewe, , United Kingdom

Site Status

Gartnavel General Hospital

Glasgow, , United Kingdom

Site Status

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Freeman Hospital

High Heaton, , United Kingdom

Site Status

St Batholomew'S Hospital

London, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Clinical Research Centre - St Georges Hospital

London, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Hope Hospital

Salford, , United Kingdom

Site Status

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status

Southampton General

Southampton, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Canada France Germany Greece Ireland Italy Netherlands New Zealand Poland South Africa Spain Sweden Switzerland United Kingdom

Other Identifiers

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M00-211

Identifier Type: -

Identifier Source: org_study_id

NCT00026481

Identifier Type: -

Identifier Source: nct_alias