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

NCT ID: NCT00036556

Last Updated: 2007-08-15

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

941 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Brief Summary

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

Detailed Description

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Conditions

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Prostatic Neoplasms

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

* Have been diagnosed with prostate cancer.
* Have a rising PSA while on hormone therapy or following surgical castration.

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.
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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Gary Gordon, 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

South Orange County Medical Research Center

Laguna Hills, California, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

VA Palo Alto

Palo Alto, 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

Dattoli Cancer Center

Sarasota, 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

Peachtree Hematology/Oncology Consultants

Atlanta, Georgia, United States

Site Status

Emory Clinic

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

Northwestern University Medical School

Chicago, Illinois, United States

Site Status

Progressive Care, S.C.

Chicago, Illinois, United States

Site Status

Christopher Ryan, MD

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

Welborn Clinic -East

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

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

Drs. Werner, Murdock, & Francis, Pa Urology Assoc.

Greenbelt, Maryland, United States

Site Status

Mid Atlantic Clinical Research

Rockville, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Michigan Medical Urology

Grand Rapids, Michigan, 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

Mississippi Center For Clinical Research, LLC

Jackson, 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

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Nevada Urology Associate

Reno, Nevada, United States

Site Status

UNM Medical Center

Albuquerque, New Mexico, 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

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

Mckay Urology

Charlotte, North Carolina, United States

Site Status

Urology Specialists Of The Carolinas

Charlotte, North Carolina, United States

Site Status

The Urology Center

Greensboro, North Carolina, United States

Site Status

University Of Cincinnati Medical Center

Cincinnati, Ohio, 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

Multimed Research

Providence, Rhode Island, United States

Site Status

University of TN - Memphis

Memphis, Tennessee, 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

The University Of TX SW Medical Center At Dallas

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

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

Princess Alexandra Hospital

Woolloongabba, , Australia

Site Status

A. Ö. Krankenhaus Mistelbach

Mistelbach, , Austria

Site Status

Klinik fur Urologie der Universitat Wien

Vienna, , Austria

Site Status

A.Z. Middelheim

Antwerp, , Belgium

Site Status

A Z St Jan

Bruges, , Belgium

Site Status

University Hospital Erasme

Brussels, , Belgium

Site Status

Uz Gent

Ghent, , Belgium

Site Status

Private Practice Dr.Vekemans

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

Professional Corporation

Fredericton, New Brunswick, 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

The Urology Resource Centre

Burlington, Ontario, Canada

Site Status

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Site Status

Hamilton & District Urology Association

Hamilton, 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

Ottawa Hospital Civic Campus

Ottawa, Ontario, Canada

Site Status

Advanced Male Fertility Clinic

Scarborough Village, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

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

Peter Lau, MD

Saskatoon, Saskatchewan, Canada

Site Status

Hôpital Cochin

Paris, Cedex 14, France

Site Status

Hopital Intercommunal

Créteil, Cedex, France

Site Status

Hôpital Salvator

Marseille, Cedex, France

Site Status

Hôpital Pasteur

Nice, Cedex, France

Site Status

Hôpital Saint Louis

Paris, Cedex, France

Site Status

Centre Hospitalier Rene Dubos

Pontoise, Cedex, France

Site Status

Hopital De Pontchaillou

Rennes, Cedex, France

Site Status

Hopital De Rangueil

Toulouse, Cedex, France

Site Status

Hôpital D´Auxerre

Auxerre, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

Hopital Bichat Claude Bernard

Paris, , France

Site Status

Allgemeines Krankenhaus Urologie

Celle, , Germany

Site Status

Universitätsklinikum Urologie

Essen, , Germany

Site Status

Universitätsklinkum

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Allgemeines Krankenhaus Barmbek

Hamburg, , Germany

Site Status

Klinik Und Poliklinik für Urologie und Kinder

Homburg / SAAR, , Germany

Site Status

Universitätsklinikum Lübeck 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

Universitat Ulm

Ulm, , Germany

Site Status

Klinikum Wuppertal GmbH

Wuppertal, , Germany

Site Status

'Alexandra' Hospital

Athens, , Greece

Site Status

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

Site Status

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

Site Status

Atrium Heerlen

Heerlen, , Netherlands

Site Status

University Hospital Rotterdam

Rotterdam, , Netherlands

Site Status

St Franciscus Gasthuis

Rotterdam, , Netherlands

Site Status

Canterbury Urology Research Trust

Christchurch, , New Zealand

Site Status

Promed Urology Ltd.

Tauranga, , New Zealand

Site Status

Samodzielny Publiczny ZOZ

Bydgoszcz, , Poland

Site Status

Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

Gdansk, , Poland

Site Status

Specjalistyczny Szpital Urologiczny

Katowice, , Poland

Site Status

Szpital Kliniczny Dzieciatka Jezus

Warsaw, , Poland

Site Status

Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Site Status

Akademia Medyczna we Wroclawiu

Wroclaw, , Poland

Site Status

Mediclinic Hospital

Petermaritzburg, 3201, 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

Site Status

Pretoria Urology Hospital

Pretoria, , South Africa

Site Status

Hospital Juan Canalejo

A Coruña, , Spain

Site Status

Hospital de la Ribera

Alcira (Valencia), , Spain

Site Status

Hospital Vall D'Hebron

Barcelona, , Spain

Site Status

Hospital de Galdakao

Galdakao-Vizcaya, , Spain

Site Status

Clinica Puerta De Hierro

Madrid, , Spain

Site Status

Hospital 12 De Octubre

Madrid, , Spain

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Hospital Carlos Haya

Málaga, , Spain

Site Status

Hospital Marques De Valdecilla

Santander, , Spain

Site Status

Instituto Valenciano De Oncologia

Valencia, , Spain

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Linkoping University Hospital

Linköping, , Sweden

Site Status

Lund University Hospital

Lund, , Sweden

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Malmo University Hospital MAS

Malmo, , Sweden

Site Status

Karolinska Hospital

Stockholm, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

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

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

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

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 United Kingdom

Other Identifiers

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M00-244

Identifier Type: -

Identifier Source: org_study_id

NCT00026455

Identifier Type: -

Identifier Source: nct_alias