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

A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

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

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Atrasentan

• Study Type: Interventional
• Enrollment (Actual): 941
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Gary Gordon, M.D., Abbott

Study record dates

Study Major Dates

• Study Start: June 1, 2001

Study Registration Dates

• First Submitted: May 10, 2002
• First Submitted That Met QC Criteria: May 10, 2002
• First Posted (Estimate): May 13, 2002

Study Record Updates

• Last Update Posted (Estimate): August 15, 2007
• Last Update Submitted That Met QC Criteria: August 13, 2007
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: Hormone-Refractory Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Endothelin Receptor Antagonists; Endothelin A Receptor Antagonists; Atrasentan
• Other Study ID Numbers: M00-244