Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT00036556
- Lead Sponsor
- Abbott
- Brief Summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 941
- Have been diagnosed with prostate cancer.
- Have a rising PSA while on hormone therapy or following surgical castration.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. Every 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (233)
Ntouch Research Corporation
๐บ๐ธDallas, Texas, United States
Princess Margaret Hospital
๐จ๐ฆToronto, Ontario, Canada
UCLA School of Medicine
๐บ๐ธLos Angeles, California, United States
Peachtree Hematology/Oncology Consultants
๐บ๐ธAtlanta, Georgia, United States
Emory Clinic
๐บ๐ธAtlanta, Georgia, United States
Sandy Springs Urology
๐บ๐ธAtlanta, Georgia, United States
Johns Hopkins Oncology Center
๐บ๐ธBaltimore, Maryland, United States
Northwestern University Medical School
๐บ๐ธChicago, Illinois, United States
Progressive Care, S.C.
๐บ๐ธChicago, Illinois, United States
Christopher Ryan, MD
๐บ๐ธChicago, Illinois, United States
Mid Atlantic Clinical Research
๐บ๐ธRockville, Maryland, United States
A Z St Jan
๐ง๐ชBrugge, Belgium
St-Elisabeth Ziekenhuis
๐ง๐ชTurnhout, Belgium
University Hospital Erasme
๐ง๐ชBruxelles, Belgium
Uz Gent
๐ง๐ชGent, Belgium
Private Practice Dr.Vekemans
๐ง๐ชHasselt, Belgium
C.H.U. Liege
๐ง๐ชLiege, Belgium
Vanderbilt University Medical Center
๐บ๐ธNashville,, Tennessee, United States
Alaska Clinical Research Center, LLC
๐บ๐ธAnchorage, Alaska, United States
Urology Associates Of San Luis Obispo
๐บ๐ธSan Luis Obispo,, California, United States
South Fl Medical Research
๐บ๐ธAventura, Florida, United States
Southeastern Urological Center, P.A.
๐บ๐ธTallahassee, Florida, United States
LSUHSC
๐บ๐ธShreveport, Louisiana, United States
University Of Cincinnati Medical Center
๐บ๐ธCincinnati,, Ohio, United States
Welborn Clinic
๐บ๐ธEvansville, Indiana, United States
Urologic Specialists Of Oklahoma, Inc.
๐บ๐ธTulsa,, Oklahoma, United States
Urology Associate Of Central California
๐บ๐ธFresno,, California, United States
Hรดpital Henri Mondor
๐ซ๐ทCreteil, France
Clinical Physiology Associates
๐บ๐ธFort Myers, Florida, United States
Iowa Urology
๐บ๐ธDes Moines, Iowa, United States
Regional Urology
๐บ๐ธShreveport, Louisiana, United States
Westmead Public Hospital
๐ฆ๐บWestmead, New South Wales, Australia
Nyack Hospital
๐บ๐ธNyack, New York, United States
Urology Centers Of Alabama
๐บ๐ธHomewood,, Alabama, United States
Urology Specialists Of The Carolinas
๐บ๐ธCharlotte,, North Carolina, United States
Albany Medical Center South Clinical Campus
๐บ๐ธAlbany, New York, United States
Pacific Clinical Research
๐บ๐ธSanta Monica, California, United States
The Medical Oncology Group
๐บ๐ธGulfport,, Mississippi, United States
Michigan Institute Of Urology, Pc
๐บ๐ธSt. Clair Shores, Michigan, United States
Lakeside Urology, PC
๐บ๐ธSt. Joseph, Michigan, United States
Dattoli Cancer Center
๐บ๐ธSarasota,, Florida, United States
Weiss Memorial Hospital
๐บ๐ธChicago,, Illinois, United States
Mckay Urology
๐บ๐ธCharlotte,, North Carolina, United States
Advanced Clinical Trials
๐บ๐ธTucson, Arizona, United States
Robin V. Smith, MD
๐บ๐ธChula Vista, California, United States
Advanced Research Institute
๐บ๐ธNew Port Richey, Florida, United States
The University Of TX SW Medical Center At Dallas
๐บ๐ธDallas, Texas, United States
Albert Einstein Medical Center
๐บ๐ธPhiladelphia, Pennsylvania, United States
South Valley Medical Plaza
๐บ๐ธGilroy, California, United States
The Urology Center
๐บ๐ธGreensboro,, North Carolina, United States
VA Palo Alto
๐บ๐ธPalo Alto, California, United States
Urologic Associates, Pc
๐บ๐ธDavenport, Iowa, United States
Royal Melbourne Hospital
๐ฆ๐บParkville, Victoria, Australia
Urology Associate, Pc
๐บ๐ธDenver,, Colorado, United States
University of Nebraska Medical Center
๐บ๐ธOmaha,, Nebraska, United States
Multimed Research
๐บ๐ธProvidence,, Rhode Island, United States
Atlanta Va Medical Center
๐บ๐ธDecatur, Georgia, United States
Urology Treatment Center
๐บ๐ธSarasota,, Florida, United States
Washington University
๐บ๐ธSt. Louis, Missouri, United States
HemOnCare, PC
๐บ๐ธBrooklyn, New York, United States
Dreyer Medical Clinic
๐บ๐ธAurora, Illinois, United States
Michigan Medical Urology
๐บ๐ธGrand Rapids, Michigan, United States
Dept of Veteran's Affairs North Texas Healthcare System
๐บ๐ธDallas, Texas, United States
Evanston Hospital Kellogg Cancer Center
๐บ๐ธEvanston, Illinois, United States
NYU Medical Center
๐บ๐ธNew York, New York, United States
Welborn Clinic -East
๐บ๐ธEvansville, Indiana, United States
Oregon Urology Specialists
๐บ๐ธEugene, Oregon, United States
Western Clinical Research, Inc.
๐บ๐ธTorrance,, California, United States
Kansas University Medical Center
๐บ๐ธKansas City,, Kansas, United States
Center for Urologic Care
๐บ๐ธWest Reading,, Pennsylvania, United States
University of TN - Memphis
๐บ๐ธMemphis, Tennessee, United States
Virginia Urology Center
๐บ๐ธRichmond,, Virginia, United States
Bayside Urology
๐ฆ๐บMentone, Victoria, Australia
Universitat Ulm
๐ฉ๐ชULM, Germany
University Of Stellenbosch
๐ฟ๐ฆCape Town, South Africa
Prince Of Wales Hospital
๐ฆ๐บRandwick, New South Wales, Australia
Hamilton & District Urology Association
๐จ๐ฆHamilton,, Ontario, Canada
Repatriation General Hospital
๐ฆ๐บDaws Park, South Australia, Australia
Princess Alexandra Hospital
๐ฆ๐บWoolloongabba, Australia
The Male Health Centres
๐จ๐ฆOakville, Ontario, Canada
Wyoming Research Foundation
๐บ๐ธCheyenne, Wyoming, United States
Dr. Gary Steinhoff, Clinical Research
๐จ๐ฆVictoria, British Columbia, Canada
Quest Clinical Trials
๐จ๐ฆMarkham, Ontario, Canada
Jack Barkin, M.D.
๐จ๐ฆNorth York, Ontario, Canada
Universitรคtsklinikum Urologie
๐ฉ๐ชEssen, Germany
Universitรคtsklinkum
๐ฉ๐ชFreiburg, Germany
Peter Lau, MD
๐จ๐ฆSaskatoon,, Saskatchewan, Canada
Kingston General Hospital
๐จ๐ฆKingston, Ontario, Canada
Clinica Urologica - Universitร Di Milano
๐ฎ๐นMilan, Italy
Medi-Clinic Hospital
๐ฟ๐ฆPietermaritzburg, South Africa
Hรดpital Pasteur
๐ซ๐ทNice, Cedex, France
Urologische Klinik Und Poliklinik Grosshadern
๐ฉ๐ชMunchen, Germany
St Vincent'S Hospital
๐ฎ๐ชDublin, Ireland
G. Genimatas Hospital
๐ฌ๐ทThessaloniki, Greece
Northwick Park Hospital
๐ฌ๐งHarrow, Middlesex, United Kingdom
Service Radio-Oncologie, Chus
๐จ๐ฆFleurimont,, Quebec, Canada
Ultramed
๐จ๐ฆPointe Claire, Quebec, Canada
Hรดpital Salvator
๐ซ๐ทMarseille, Cedex, France
Universitรคtsklinikum Lรผbeck Urologie
๐ฉ๐ชLรผbeck, Germany
Mediclinic Hospital
๐ฟ๐ฆPetermaritzburg, 3201, South Africa
Klinik Und Poliklinik fรผr Urologie und Kinder
๐ฉ๐ชHomburg / Saar, Germany
University Of Natal - Nelson R Mandela School of Medicine
๐ฟ๐ฆDurban, South Africa
'Alexandra' Hospital
๐ฌ๐ทAthens, Greece
Pe.Pa.G.N.I Hospital
๐ฌ๐ทHeraklion, Greece
St Franciscus Gasthuis
๐ณ๐ฑRotterdam, Netherlands
Linkoping University Hospital
๐ธ๐ชLinkoping, Sweden
Lund University Hospital
๐ธ๐ชLund, Sweden
Karolinska Hospital
๐ธ๐ชStockholm, Sweden
Klinikum Wuppertal GmbH
๐ฉ๐ชWuppertal, Germany
Promed Urology Ltd.
๐ณ๐ฟTauranga, New Zealand
Hopital Bichat Claude Bernard
๐ซ๐ทParis, France
Universitรคtsklinikum Hamburg-Eppendorf
๐ฉ๐ชHamburg, Germany
Hospital Carlos Haya
๐ช๐ธMalaga, Spain
Allgemeines Krankenhaus Barmbek
๐ฉ๐ชHamburg, Germany
Southampton General
๐ฌ๐งSouthampton, United Kingdom
Kenridge St Joseph Wingl
๐ฟ๐ฆParktown, South Africa
Leighton Hospital
๐ฌ๐งCrewe, United Kingdom
Sahlgrenska University Hospital
๐ธ๐ชGothenburg, Sweden
Hospital Vall D'Hebron
๐ช๐ธBarcelona, Spain
Clinica Puerta De Hierro
๐ช๐ธMadrid, Spain
Uppsala University Hospital
๐ธ๐ชUppsala, Sweden
St Richard'S Hospital
๐ฌ๐งChichester, United Kingdom
Clinica Urologica I - Universitร di Bari
๐ฎ๐นBari, Italy
Istituto Nazionale per la Ricerca sul Cancro -IST
๐ฎ๐นGenoa, Italy
Istituto di Urologia
๐ฎ๐นPadova, Italy
Tom Baker Cancer Center
๐จ๐ฆCalgary,, Alberta, Canada
Probidity Medical Research
๐จ๐ฆKitchener, Ontario, Canada
Ottawa Hospital Civic Campus
๐จ๐ฆOttawa, Ontario, Canada
London Health Sciences Centre
๐จ๐ฆLondon, Ontario, Canada
Walk-In Clinic
๐จ๐ฆNorth Bay, Ontario, Canada
Advanced Male Fertility Clinic
๐จ๐ฆScarborough,, Ontario, Canada
Northeastern Ontario Regional Cancer Centre
๐จ๐ฆSudbury,, Ontario, Canada
Sunnybrook Health Sciences Centre
๐จ๐ฆToronto, Ontario, Canada
Hopital Notre-Dame
๐จ๐ฆMontreal, Quebec, Canada
Chuq Pavillon Hotel-Dieu
๐จ๐ฆQuebec, Canada
Hรดpital Saint Louis
๐ซ๐ทParis, Cedex, France
Hopital De Rangueil
๐ซ๐ทToulouse, Cedex, France
Hรดpital DยดAuxerre
๐ซ๐ทAuxerre, France
Addenbrookes Hospital
๐ฌ๐งCambridge, United Kingdom
Southmead Hospital
๐ฌ๐งBristol, United Kingdom
St Batholomew'S Hospital
๐ฌ๐งLondon, United Kingdom
Royal Free Hospital
๐ฌ๐งLondon, United Kingdom
Gartnavel General Hospital
๐ฌ๐งGlasgow, United Kingdom
Glasgow Royal Infirmary
๐ฌ๐งGlasgow, United Kingdom
Hope Hospital
๐ฌ๐งSalford, United Kingdom
Hillcrest Urological Medical Group, Inc.
๐บ๐ธSan Diego, California, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Urology Associates
๐บ๐ธNashville, Tennessee, United States
Uthscsa
๐บ๐ธSan Antonio, Texas, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
Western Urological Clinic
๐บ๐ธSalt Lake City, Utah, United States
Seattle Urological Associates
๐บ๐ธSeattle, Washington, United States
University Of Washington School Of Medicine
๐บ๐ธSeattle, Washington, United States
Klinikum Rechts Der Isar
๐ฉ๐ชMunchen, Germany
Hospital de Galdakao
๐ช๐ธGaldakao-Vizcaya, Spain
Hospital Marques De Valdecilla
๐ช๐ธSantander, Spain
Hospital 12 De Octubre
๐ช๐ธMadrid, Spain
Nevada Urology Associate
๐บ๐ธReno, Nevada, United States
Instituto Valenciano De Oncologia
๐ช๐ธValencia, Spain
Clinical Research Centre - St Georges Hospital
๐ฌ๐งLondon, United Kingdom
South Orange County Medical Research Center
๐บ๐ธLaguna Hills, California, United States
San Diego Urology Center
๐บ๐ธLa Mesa, California, United States
Arkansas Urologial Associates, PA
๐บ๐ธLittle Rock, Arkansas, United States
Mississippi Center For Clinical Research, LLC
๐บ๐ธJackson, Mississippi, United States
Drs. Werner, Murdock, & Francis, Pa Urology Assoc.
๐บ๐ธGreenbelt, Maryland, United States
St. Joseph Oncology
๐บ๐ธSt. Joseph, Missouri, United States
Beth Israel Medical Center
๐บ๐ธNew York, New York, United States
UNM Medical Center
๐บ๐ธAlbuquerque, New Mexico, United States
University Of Pittsburgh
๐บ๐ธPittsburgh, Pennsylvania, United States
Urologic Associates of Allentown
๐บ๐ธAllentown, Pennsylvania, United States
Milton S. Hershey Medical Center
๐บ๐ธHershey, Pennsylvania, United States
Blumenthal Cancer Center
๐บ๐ธCharlotte, North Carolina, United States
Urological Associates Of Lancaster
๐บ๐ธLancaster, Pennsylvania, United States
Scott & White Memorial Hospital
๐บ๐ธTemple,, Texas, United States
Midwest Research Specialists, LLC
๐บ๐ธMilwaukee, Wisconsin, United States
Royal Brisbane Hospital
๐ฆ๐บHerston, Queensland, Australia
Anthony Middleton, M.D.
๐บ๐ธSalt Lake City,, Utah, United States
University Of Vermont
๐บ๐ธBurlington,, Vermont, United States
Jeffrey Frankel, M.D.
๐บ๐ธSeattle,, Washington, United States
Madigan Army Medical Center
๐บ๐ธTacoma,, Washington, United States
Valley Professional Centre
๐จ๐ฆKentville, Nova Scotia, Canada
Cross Cancer Institute
๐จ๐ฆEdmonton,, Alberta, Canada
Abbott Clinic
๐จ๐ฆWinnipeg, Manitoba, Canada
Professional Corporation
๐จ๐ฆFredericton, New Brunswick, Canada
Dr. Cal Andreou
๐จ๐ฆSurrey, British Columbia, Canada
Queen Elizabeth II Health Sciences Center
๐จ๐ฆHalifax, Nova Scotia, Canada
The Urology Resource Centre
๐จ๐ฆBurlington, Ontario, Canada
Hopital De Pontchaillou
๐ซ๐ทRennes, Cedex, France
Royal Victoria Hospital
๐จ๐ฆMontreal, Quebec, Canada
Hopital Intercommunal
๐ซ๐ทCreteil, Cedex, France
Centre Hospitalier Rene Dubos
๐ซ๐ทPontoise, Cedex, France
Hรดpital Cochin
๐ซ๐ทParis, Cedex 14, France
Rijnstate Hospital
๐ณ๐ฑArnhem, Netherlands
Allgemeines Krankenhaus Urologie
๐ฉ๐ชCelle, Germany
Universitรคtsklinikum Mannheim
๐ฉ๐ชMannheim, Germany
Atrium Heerlen
๐ณ๐ฑHeerlen, Netherlands
Istituto Europeo di Oncologia
๐ฎ๐นMilan, Italy
Policlinico G. B. Rossi
๐ฎ๐นVerona, Italy
Medisch Spectrun Twente
๐ณ๐ฑEnschede, Netherlands
Canterbury Urology Research Trust
๐ณ๐ฟChristchurch, New Zealand
University Hospital Rotterdam
๐ณ๐ฑRotterdam, Netherlands
Specjalistyczny Szpital Urologiczny
๐ต๐ฑKatowice, Poland
Szpital Kliniczny Dzieciatka Jezus
๐ต๐ฑWarszawa, Poland
Pretoria Urology Hospital
๐ฟ๐ฆPretoria, South Africa
Hospital de la Ribera
๐ช๐ธAlcira (Valencia), Spain
Hospital Juan Canalejo
๐ช๐ธLa Coruna, Spain
Medical Centre
๐ฟ๐ฆPietermaritzburg, South Africa
St Lukes Hospital
๐ฌ๐งBradford, West Yorkshire, United Kingdom
Malmo University Hospital MAS
๐ธ๐ชMalmo, Sweden
Royal Hallamshire Hospital
๐ฌ๐งSheffield, United Kingdom
Klinik fur Urologie der Universitat Wien
๐ฆ๐นWien, Austria
Mater Misericordiae Hospital
๐ฎ๐ชDublin, Ireland
Taunton And Somerset Hospital
๐ฌ๐งTaunton, Somerset, United Kingdom
Dr. P. J. Pommerville, Inc.
๐จ๐ฆVictoria, British Columbia, Canada
Western General Hospital
๐ฌ๐งEdinburgh,, Scotland, United Kingdom
Samodzielny Publiczny ZOZ
๐ต๐ฑBydgoszcz, Poland
Katedra i Klinika Urologii - Akademia Medyczna w Gdansku
๐ต๐ฑGdansk, Poland
Lister Hospital
๐ฌ๐งStevenage, Hertfordshire, United Kingdom
Clatterbridge Centre For Oncology
๐ฌ๐งBebington, Wirral, United Kingdom
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
Vancouver Hospital & Health Sciences Centre
๐จ๐ฆVancouver, British Columbia, Canada
A. ร. Krankenhaus Mistelbach
๐ฆ๐นMistelbach, Austria
Akademia Medyczna we Wroclawiu
๐ต๐ฑWroclaw, Poland
The Institute Of Cancer Research - Royal Marsden Hospital
๐ฌ๐งSutton, Surrey, United Kingdom
Wilson Urology
๐จ๐ฆKelowna, British Columbia, Canada
Tallaght Hospital
๐ฎ๐ชDublin, Ireland
Instytut im. Marii Sklodowskiej-Curie
๐ต๐ฑWarszawa, Poland
Royal Devon And Exeter Hospital
๐ฌ๐งExeter,, Devon, United Kingdom
Billings Oncology Associates
๐บ๐ธBillings,, Montana, United States
A.Z. Middelheim
๐ง๐ชAntwerpen, Belgium
The University Of North Carolina At Chapel Hill
๐บ๐ธChapel Hill, North Carolina, United States
Peter Maccallum Cancer Institute
๐ฆ๐บEast Melbourne, Victoria, Australia
Amc
๐ณ๐ฑAmsterdam, Netherlands