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Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
This study has been completed.
First Received: May 10, 2002   Last Updated: August 13, 2007   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00036556
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
Drug: Atrasentan
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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. [ Time Frame: Every 12 weeks ]

Enrollment: 941
Study Start Date: June 2001
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036556

  Hide Study Locations
Locations
United States, Alabama
Urology Centers Of Alabama
Homewood,, Alabama, United States, 35205
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, Arizona
Advanced Clinical Trials
Tucson, Arizona, United States, 85712
United States, Arkansas
Arkansas Urologial Associates, PA
Little Rock, Arkansas, United States, 72205
United States, California
Hillcrest Urological Medical Group, Inc.
San Diego, California, United States, 92103
Pacific Clinical Research
Santa Monica, California, United States, 90404
Robin V. Smith, MD
Chula Vista, California, United States, 91910
South Orange County Medical Research Center
LAGUNA HILLS, California, United States, 92653
South Valley Medical Plaza
GILROY, California, United States, 95020-3535
Urology Associate Of Central California
Fresno,, California, United States, 93720
Urology Associates Of San Luis Obispo
San Luis Obispo,, California, United States, 93405
Western Clinical Research, Inc.
Torrance,, California, United States, 90505-4763
VA Palo Alto
PALO ALTO, California, United States, 94304
San Diego Urology Center
La Mesa, California, United States, 91942
UCLA School of Medicine
Los Angeles, California, United States, 90095-1738
United States, Colorado
Urology Associate, Pc
Denver,, Colorado, United States, 80210
United States, Florida
Advanced Research Institute
New Port Richey, Florida, United States, 34652
Clinical Physiology Associates
FORT MYERS, Florida, United States, 33916
Dattoli Cancer Center
Sarasota,, Florida, United States, 34237
Southeastern Urological Center, P.A.
TALLAHASSEE, Florida, United States, 32308
Urology Treatment Center
Sarasota,, Florida, United States, 34239
South Fl Medical Research
Aventura, Florida, United States, 33180
United States, Georgia
Atlanta Va Medical Center
Decatur, Georgia, United States, 30033
Sandy Springs Urology
Atlanta, Georgia, United States, 30328
Emory Clinic
Atlanta, Georgia, United States, 30322
Peachtree Hematology/Oncology Consultants
Atlanta, Georgia, United States, 30309
United States, Illinois
Weiss Memorial Hospital
Chicago,, Illinois, United States, 60640
Progressive Care, S.C.
Chicago, Illinois, United States, 60631
Evanston Hospital Kellogg Cancer Center
Evanston, Illinois, United States, 60201
Northwestern University Medical School
Chicago, Illinois, United States, 60611-3010
Christopher Ryan, MD
Chicago, Illinois, United States, 60637-1470
Dreyer Medical Clinic
Aurora, Illinois, United States, 60506
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713
Welborn Clinic -East
Evansville, Indiana, United States, 47714-0981
United States, Iowa
Iowa Urology
Des Moines, Iowa, United States, 50309
Urologic Associates, Pc
Davenport, Iowa, United States, 52807
United States, Kansas
Kansas University Medical Center
Kansas City,, Kansas, United States, 66160-7390
United States, Louisiana
LSUHSC
Shreveport, Louisiana, United States, 71130
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-1000
Mid Atlantic Clinical Research
Rockville, Maryland, United States, 20850
Drs. Werner, Murdock, & Francis, Pa Urology Assoc.
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2617
United States, Michigan
Lakeside Urology, PC
St. Joseph, Michigan, United States, 49085
Michigan Institute Of Urology, Pc
St. Clair Shores, Michigan, United States, 48081
Michigan Medical Urology
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
The Medical Oncology Group
Gulfport,, Mississippi, United States, 39501
Mississippi Center For Clinical Research, LLC
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Joseph Oncology
St. Joseph, Missouri, United States, 64507
Washington University
St. Louis, Missouri, United States, 63110
United States, Montana
Billings Oncology Associates
Billings,, Montana, United States, 59101
United States, Nebraska
University of Nebraska Medical Center
OMAHA,, Nebraska, United States, 68198-7860
United States, Nevada
Nevada Urology Associate
Reno, Nevada, United States, 89509
United States, New Mexico
UNM Medical Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Medical Center South Clinical Campus
Albany, New York, United States, 12208-3499
Nyack Hospital
Nyack, New York, United States, 10960
HemOnCare, PC
Brooklyn, New York, United States, 11235
Beth Israel Medical Center
New York, New York, United States, 10003
NYU Medical Center
New York, New York, United States, 10016
United States, North Carolina
Blumenthal Cancer Center
CHARLOTTE, North Carolina, United States, 28203
The University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7235
The Urology Center
Greensboro,, North Carolina, United States, 27401
Mckay Urology
Charlotte,, North Carolina, United States, 28204
Urology Specialists Of The Carolinas
Charlotte,, North Carolina, United States, 28207
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
University Of Cincinnati Medical Center
Cincinnati,, Ohio, United States, 45267-0589
United States, Oklahoma
Urologic Specialists Of Oklahoma, Inc.
Tulsa,, Oklahoma, United States, 74104-5433
United States, Oregon
Oregon Urology Specialists
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Center for Urologic Care
West Reading,, Pennsylvania, United States, 19611
Urological Associates Of Lancaster
Lancaster, Pennsylvania, United States, 17604-3200
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Urologic Associates of Allentown
Allentown, Pennsylvania, United States, 18103
United States, Rhode Island
Multimed Research
Providence,, Rhode Island, United States, 02905
United States, Tennessee
Urology Associates
Nashville, Tennessee, United States, 37209
Vanderbilt University Medical Center
NASHVILLE,, Tennessee, United States, 37232-2765
University of TN - Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
Dept of Veteran's Affairs North Texas Healthcare System
Dallas, Texas, United States, 75216
Ntouch Research Corporation
Dallas, Texas, United States, 75230
Scott & White Memorial Hospital
TEMPLE,, Texas, United States, 76508
Uthscsa
San Antonio, Texas, United States, 78229
The University Of TX SW Medical Center At Dallas
Dallas, Texas, United States, 75390-9110
United States, Utah
Anthony Middleton, M.D.
Salt Lake City,, Utah, United States, 84102
Western Urological Clinic
Salt Lake City, Utah, United States, 84107
United States, Vermont
University Of Vermont
Burlington,, Vermont, United States, 05403
United States, Virginia
Virginia Urology Center
Richmond,, Virginia, United States, 23230
United States, Washington
Jeffrey Frankel, M.D.
Seattle,, Washington, United States, 98166-3059
Madigan Army Medical Center
Tacoma,, Washington, United States, 98431
Seattle Urological Associates
Seattle, Washington, United States, 98104
University Of Washington School Of Medicine
Seattle, Washington, United States, 98109-1023
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, United States, 53209
United States, Wyoming
Wyoming Research Foundation
CHEYENNE, Wyoming, United States, 82001
Australia
Princess Alexandra Hospital
Woolloongabba, Australia, QLD 4102
Australia, New South Wales
Prince Of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Public Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane Hospital
HERSTON, Queensland, Australia, 4029
Australia, South Australia
Repatriation General Hospital
Daws Park, South Australia, Australia, 5041
Australia, Victoria
Bayside Urology
Mentone, Victoria, Australia, 3194
Peter Maccallum Cancer Institute
East Melbourne, Victoria, Australia, 3002
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Austria
A. Ö. Krankenhaus Mistelbach
Mistelbach, Austria, 2130
Klinik fur Urologie der Universitat Wien
Wien, Austria, A-1090
Belgium
A Z St Jan
BRUGGE, Belgium, 8000
C.H.U. Liege
LIEGE, Belgium, 4000
St-Elisabeth Ziekenhuis
TURNHOUT, Belgium, 2300
A.Z. Middelheim
Antwerpen, Belgium, 2020
University Hospital Erasme
BRUXELLES, Belgium, 1070
Uz Gent
GENT, Belgium, 9000
Private Practice Dr.Vekemans
Hasselt, Belgium, 3500
Canada
Chuq Pavillon Hotel-Dieu
Quebec, Canada, G1R 2J6
Canada, Alberta
Cross Cancer Institute
Edmonton,, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Center
Calgary,, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, Canada, V5Z 3J5
Dr. P. J. Pommerville, Inc.
Victoria, British Columbia, Canada, V8T5G1
Dr. Gary Steinhoff, Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
Dr. Cal Andreou
Surrey, British Columbia, Canada, V3V 1N1
Wilson Urology
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Manitoba
Abbott Clinic
Winnipeg, Manitoba, Canada, R3C 1V8
Canada, New Brunswick
Professional Corporation
Fredericton, New Brunswick, Canada, E3B 5B8
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Valley Professional Centre
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Jack Barkin, M.D.
North York, Ontario, Canada, M6A 3B5
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Northeastern Ontario Regional Cancer Centre
Sudbury,, Ontario, Canada, P3E 5J1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
The Male Health Centres
Barrie, Ontario, Canada, L4M 4S5
The Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
The Urology Resource Centre
Burlington, Ontario, Canada, L7S 1V2
Advanced Male Fertility Clinic
Scarborough,, Ontario, Canada, M1S 4V5
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Ottawa Hospital Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Hamilton & District Urology Association
Hamilton,, Ontario, Canada, L8N 1T8
Probidity Medical Research
Kitchener, Ontario, Canada, N2M 5N6
Quest Clinical Trials
Markham, Ontario, Canada, L6B 1A1
Walk-In Clinic
North Bay, Ontario, Canada, P1B 4Z2
Canada, Quebec
Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Service Radio-Oncologie, Chus
Fleurimont,, Quebec, Canada, J1H 5N4
Ultramed
Pointe Claire, Quebec, Canada, H9R 4S3
Ultramed
Pointe Claire, Quebec, Canada, H9R 4S3
Canada, Saskatchewan
Peter Lau, MD
SASKATOON,, Saskatchewan, Canada, S7K 3H3
France
Hôpital D´Auxerre
AUXERRE, France, 89000
Hôpital Henri Mondor
CRETEIL, France, 94010
Hopital Bichat Claude Bernard
PARIS, France, 75018
France, CEDEX
Hopital De Pontchaillou
RENNES, CEDEX, France, 35033
Hopital De Rangueil
TOULOUSE, CEDEX, France, 31043
Hopital Intercommunal
CRETEIL, CEDEX, France, 94010
Hôpital Pasteur
NICE, CEDEX, France, 3 06202
France, Cedex
Hôpital Salvator
Marseille, Cedex, France, 9 13274
France, CEDEX
Hôpital Saint Louis
PARIS, CEDEX, France, 10 75475
Centre Hospitalier Rene Dubos
PONTOISE, CEDEX, France, 95303
France, CEDEX 14
Hôpital Cochin
PARIS, CEDEX 14, France, 75679
Germany
Universitätsklinikum Lübeck Urologie
LÜBECK, Germany, 23538
Allgemeines Krankenhaus Urologie
CELLE, Germany, 29223
Klinik Und Poliklinik für Urologie und Kinder
HOMBURG / SAAR, Germany, 66421
Klinikum Rechts Der Isar
Munchen, Germany, 81675
Klinikum Wuppertal GmbH
WUPPERTAL, Germany, 42283
Universitat Ulm
ULM, Germany, 89070
Allgemeines Krankenhaus Barmbek
HAMBURG, Germany, 22291
Universitätsklinikum Mannheim
MANNHEIM, Germany, 68135
Universitätsklinikum Urologie
ESSEN, Germany, 45147
Universitätsklinkum
FREIBURG, Germany, 79106
Urologische Klinik Und Poliklinik Grosshadern
MUNCHEN, Germany, 81377
Universitätsklinikum Hamburg-Eppendorf
HAMBURG, Germany, 20246
Greece
'Alexandra' Hospital
ATHENS, Greece, 115 27
G. Genimatas Hospital
THESSALONIKI, Greece, 546 35
Pe.Pa.G.N.I Hospital
Heraklion, Greece, 711 10
Ireland
Mater Misericordiae Hospital
Dublin, Ireland, 7
St Vincent'S Hospital
DUBLIN, Ireland, 4
Tallaght Hospital
DUBLIN, Ireland, 24
Italy
Istituto di Urologia
PADOVA, Italy, 35128
Clinica Urologica I - Università di Bari
BARI, Italy, 70124
Clinica Urologica - Università Di Milano
Milan, Italy, 20142
Istituto Europeo di Oncologia
MILAN, Italy, 20141
Istituto Nazionale per la Ricerca sul Cancro -IST
Genoa, Italy, 16132
Policlinico G. B. Rossi
Verona, Italy, 37134
Netherlands
Amc
AMSTERDAM, Netherlands, 1105 AZ
St Franciscus Gasthuis
ROTTERDAM, Netherlands, 3045 PM
Medisch Spectrun Twente
ENSCHEDE, Netherlands, 7500 KA
Rijnstate Hospital
ARNHEM, Netherlands, 6815 AD
Atrium Heerlen
HEERLEN, Netherlands, 6401 CX
University Hospital Rotterdam
ROTTERDAM, Netherlands, 3015 GD
New Zealand
Canterbury Urology Research Trust
Christchurch, New Zealand
Promed Urology Ltd.
Tauranga, New Zealand
Poland
Akademia Medyczna we Wroclawiu
Wroclaw, Poland, 50-043
Samodzielny Publiczny ZOZ
Bydgoszcz, Poland, 85-168
Instytut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Szpital Kliniczny Dzieciatka Jezus
Warszawa, Poland, 02-034
Katedra i Klinika Urologii - Akademia Medyczna w Gdansku
GDANSK, Poland, 80-742
Specjalistyczny Szpital Urologiczny
Katowice, Poland, 40-073
South Africa
Kenridge St Joseph Wingl
PARKTOWN, South Africa, 2010
Medi-Clinic Hospital
PIETERMARITZBURG, South Africa, 3201
University Of Stellenbosch
CAPE TOWN, South Africa
Pretoria Urology Hospital
PRETORIA, South Africa, 0083
University Of Natal - Nelson R Mandela School of Medicine
Durban, South Africa, 4013
Medical Centre
PIETERMARITZBURG, South Africa, 3201
South Africa, 3201
Mediclinic Hospital
Petermaritzburg, 3201, South Africa
Spain
Clinica Puerta De Hierro
MADRID, Spain, 28035
Hospital 12 De Octubre
MADRID, Spain, 28041
Hospital Carlos Haya
MALAGA, Spain, 29009
Hospital Vall D'Hebron
BARCELONA, Spain, 08035
Hospital Marques De Valdecilla
SANTANDER, Spain, 39008
Hospital Juan Canalejo
LA CORUNA, Spain, 15006
Instituto Valenciano De Oncologia
VALENCIA, Spain, 46009
Hospital de Galdakao
Galdakao-Vizcaya, Spain, 48960
Hospital de la Ribera
Alcira (Valencia), Spain, 46600
Sweden
Karolinska Hospital
STOCKHOLM, Sweden, 171 76
Sahlgrenska University Hospital
GOTHENBURG, Sweden, 41345
Lund University Hospital
LUND, Sweden, 221 85
Malmo University Hospital MAS
MALMO, Sweden, 205 02
Linkoping University Hospital
Linkoping, Sweden, 501 85
Uppsala University Hospital
UPPSALA, Sweden, 751 85
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 2QQ
Clinical Research Centre - St Georges Hospital
LONDON, United Kingdom, SW17 0QT
Gartnavel General Hospital
GLASGOW, United Kingdom, G12 0YN
Leighton Hospital
CREWE, United Kingdom, CW1 4QJ
Hope Hospital
SALFORD, United Kingdom, M6 8HD
Glasgow Royal Infirmary
GLASGOW, United Kingdom, G31 2ER
Royal Free Hospital
LONDON, United Kingdom, NW3 2QG
Southampton General
Southampton, United Kingdom, SO16 6YD
Southmead Hospital
BRISTOL, United Kingdom, BS10 5NB
St Batholomew'S Hospital
LONDON, United Kingdom, EC1A 7BE
St Richard'S Hospital
CHICHESTER, United Kingdom, PO19 4SE
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
United Kingdom, Devon
Royal Devon And Exeter Hospital
EXETER,, Devon, United Kingdom, EX2 5DW
United Kingdom, Hertfordshire
Lister Hospital
STEVENAGE, Hertfordshire, United Kingdom, SG1 4AB
United Kingdom, Middlesex
Northwick Park Hospital
HARROW, Middlesex, United Kingdom, HA1 3UJ
United Kingdom, Scotland
Western General Hospital
EDINBURGH,, Scotland, United Kingdom, EH4 2XU
United Kingdom, Somerset
Taunton And Somerset Hospital
TAUNTON, Somerset, United Kingdom, TA1 5DA
United Kingdom, Surrey
The Institute Of Cancer Research - Royal Marsden Hospital
SUTTON, Surrey, United Kingdom, SM2 5PT
United Kingdom, West Yorkshire
St Lukes Hospital
BRADFORD, West Yorkshire, United Kingdom, BD5 0NA
United Kingdom, WIRRAL
Clatterbridge Centre For Oncology
Bebington, WIRRAL, United Kingdom, CH63 4JY
Sponsors and Collaborators
Abbott
Investigators
Study Director: Gary Gordon, M.D. Abbott
  More Information

No publications provided

Study ID Numbers: M00-244
Study First Received: May 10, 2002
Last Updated: August 13, 2007
ClinicalTrials.gov Identifier: NCT00036556     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Hormone-Refractory Prostate Cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009