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
1 other identifier
interventional
941
16 countries
232
Brief Summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 10, 2002
CompletedFirst Posted
Study publicly available on registry
May 13, 2002
CompletedAugust 15, 2007
August 1, 2007
May 10, 2002
August 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Have been diagnosed with prostate cancer.
- Have a rising PSA while on hormone therapy or following surgical castration.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (234)
Urology Centers Of Alabama
Homewood, Alabama, 35205, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Advanced Clinical Trials
Tucson, Arizona, 85712, United States
Arkansas Urologial Associates, PA
Little Rock, Arkansas, 72205, United States
Robin V. Smith, MD
Chula Vista, California, 91910, United States
Urology Associate Of Central California
Fresno, California, 93720, United States
South Valley Medical Plaza
Gilroy, California, 95020-3535, United States
San Diego Urology Center
La Mesa, California, 91942, United States
South Orange County Medical Research Center
Laguna Hills, California, 92653, United States
UCLA School of Medicine
Los Angeles, California, 90095-1738, United States
VA Palo Alto
Palo Alto, California, 94304, United States
Hillcrest Urological Medical Group, Inc.
San Diego, California, 92103, United States
Urology Associates Of San Luis Obispo
San Luis Obispo, California, 93405, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
Western Clinical Research, Inc.
Torrance, California, 90505-4763, United States
Urology Associate, Pc
Denver, Colorado, 80210, United States
South Fl Medical Research
Aventura, Florida, 33180, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
Advanced Research Institute
New Port Richey, Florida, 34652, United States
Dattoli Cancer Center
Sarasota, Florida, 34237, United States
Urology Treatment Center
Sarasota, Florida, 34239, United States
Southeastern Urological Center, P.A.
Tallahassee, Florida, 32308, United States
Peachtree Hematology/Oncology Consultants
Atlanta, Georgia, 30309, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Sandy Springs Urology
Atlanta, Georgia, 30328, United States
Atlanta Va Medical Center
Decatur, Georgia, 30033, United States
Dreyer Medical Clinic
Aurora, Illinois, 60506, United States
Northwestern University Medical School
Chicago, Illinois, 60611-3010, United States
Progressive Care, S.C.
Chicago, Illinois, 60631, United States
Christopher Ryan, MD
Chicago, Illinois, 60637-1470, United States
Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Evanston Hospital Kellogg Cancer Center
Evanston, Illinois, 60201, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
Welborn Clinic -East
Evansville, Indiana, 47714-0981, United States
Urologic Associates, Pc
Davenport, Iowa, 52807, United States
Iowa Urology
Des Moines, Iowa, 50309, United States
Kansas University Medical Center
Kansas City, Kansas, 66160-7390, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
LSUHSC
Shreveport, Louisiana, 71130, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-1000, United States
Drs. Werner, Murdock, & Francis, Pa Urology Assoc.
Greenbelt, Maryland, 20770, United States
Mid Atlantic Clinical Research
Rockville, Maryland, 20850, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2617, United States
Michigan Medical Urology
Grand Rapids, Michigan, 49503, United States
Michigan Institute Of Urology, Pc
Saint Clair Shores, Michigan, 48081, United States
Lakeside Urology, PC
Saint Joseph, Michigan, 49085, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Medical Oncology Group
Gulfport, Mississippi, 39501, United States
Mississippi Center For Clinical Research, LLC
Jackson, Mississippi, 39216, United States
St. Joseph Oncology
Saint Joseph, Missouri, 64507, United States
Washington University
St Louis, Missouri, 63110, United States
Billings Oncology Associates
Billings, Montana, 59101, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7860, United States
Nevada Urology Associate
Reno, Nevada, 89509, United States
UNM Medical Center
Albuquerque, New Mexico, 87131, United States
Albany Medical Center South Clinical Campus
Albany, New York, 12208-3499, United States
HemOnCare, PC
Brooklyn, New York, 11235, United States
Beth Israel Medical Center
New York, New York, 10003, United States
NYU Medical Center
New York, New York, 10016, United States
Nyack Hospital
Nyack, New York, 10960, United States
The University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599-7235, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28203, United States
Mckay Urology
Charlotte, North Carolina, 28204, United States
Urology Specialists Of The Carolinas
Charlotte, North Carolina, 28207, United States
The Urology Center
Greensboro, North Carolina, 27401, United States
University Of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0589, United States
Urologic Specialists Of Oklahoma, Inc.
Tulsa, Oklahoma, 74104-5433, United States
Oregon Urology Specialists
Eugene, Oregon, 97401, United States
Urologic Associates of Allentown
Allentown, Pennsylvania, 18103, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Urological Associates Of Lancaster
Lancaster, Pennsylvania, 17604-3200, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Center for Urologic Care
West Reading, Pennsylvania, 19611, United States
Multimed Research
Providence, Rhode Island, 02905, United States
University of TN - Memphis
Memphis, Tennessee, 38104, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2765, United States
Dept of Veteran's Affairs North Texas Healthcare System
Dallas, Texas, 75216, United States
Ntouch Research Corporation
Dallas, Texas, 75230, United States
The University Of TX SW Medical Center At Dallas
Dallas, Texas, 75390-9110, United States
Uthscsa
San Antonio, Texas, 78229, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Anthony Middleton, M.D.
Salt Lake City, Utah, 84102, United States
Western Urological Clinic
Salt Lake City, Utah, 84107, United States
University Of Vermont
Burlington, Vermont, 05403, United States
Virginia Urology Center
Richmond, Virginia, 23230, United States
Seattle Urological Associates
Seattle, Washington, 98104, United States
University Of Washington School Of Medicine
Seattle, Washington, 98109-1023, United States
Jeffrey Frankel, M.D.
Seattle, Washington, 98166-3059, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, 53209, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Wyoming Research Foundation
Cheyenne, Wyoming, 82001, United States
Prince Of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Public Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Repatriation General Hospital
Daws Park, South Australia, 5041, Australia
Peter Maccallum Cancer Institute
East Melbourne, Victoria, 3002, Australia
Bayside Urology
Mentone, Victoria, 3194, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Princess Alexandra Hospital
Woolloongabba, QLD 4102, Australia
A. Ö. Krankenhaus Mistelbach
Mistelbach, 2130, Austria
Klinik fur Urologie der Universitat Wien
Vienna, A-1090, Austria
A.Z. Middelheim
Antwerp, 2020, Belgium
A Z St Jan
Bruges, 8000, Belgium
University Hospital Erasme
Brussels, 1070, Belgium
Uz Gent
Ghent, 9000, Belgium
Private Practice Dr.Vekemans
Hasselt, 3500, Belgium
C.H.U. Liege
Liège, 4000, Belgium
St-Elisabeth Ziekenhuis
Turnhout, 2300, Belgium
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Wilson Urology
Kelowna, British Columbia, V1Y 2H4, Canada
Dr. Cal Andreou
Surrey, British Columbia, V3V 1N1, Canada
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, V5Z 3J5, Canada
Dr. P. J. Pommerville, Inc.
Victoria, British Columbia, V8T5G1, Canada
Dr. Gary Steinhoff, Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
Abbott Clinic
Winnipeg, Manitoba, R3C 1V8, Canada
Professional Corporation
Fredericton, New Brunswick, E3B 5B8, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 2Y9, Canada
Valley Professional Centre
Kentville, Nova Scotia, B4N 4K9, Canada
The Male Health Centres
Barrie, Ontario, L4M 4S5, Canada
The Urology Resource Centre
Burlington, Ontario, L7S 1V2, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton & District Urology Association
Hamilton, Ontario, L8N 1T8, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Probidity Medical Research
Kitchener, Ontario, N2M 5N6, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Quest Clinical Trials
Markham, Ontario, L6B 1A1, Canada
Walk-In Clinic
North Bay, Ontario, P1B 4Z2, Canada
Jack Barkin, M.D.
North York, Ontario, M6A 3B5, Canada
The Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Ottawa Hospital Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Advanced Male Fertility Clinic
Scarborough Village, Ontario, M1S 4V5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Service Radio-Oncologie, Chus
Fleurimont, Quebec, J1H 5N4, Canada
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Ultramed
Pointe-Claire, Quebec, H9R 4S3, Canada
Chuq Pavillon Hotel-Dieu
Québec, Quebec, G1R 2J6, Canada
Peter Lau, MD
Saskatoon, Saskatchewan, S7K 3H3, Canada
Hôpital Cochin
Paris, Cedex 14, 75679, France
Hopital Intercommunal
Créteil, Cedex, 94010, France
Hôpital Salvator
Marseille, Cedex, 9 13274, France
Hôpital Pasteur
Nice, Cedex, 3 06202, France
Hôpital Saint Louis
Paris, Cedex, 10 75475, France
Centre Hospitalier Rene Dubos
Pontoise, Cedex, 95303, France
Hopital De Pontchaillou
Rennes, Cedex, 35033, France
Hopital De Rangueil
Toulouse, Cedex, 31043, France
Hôpital D´Auxerre
Auxerre, 89000, France
Hôpital Henri Mondor
Créteil, 94010, France
Hopital Bichat Claude Bernard
Paris, 75018, France
Allgemeines Krankenhaus Urologie
Celle, 29223, Germany
Universitätsklinikum Urologie
Essen, 45147, Germany
Universitätsklinkum
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Allgemeines Krankenhaus Barmbek
Hamburg, 22291, Germany
Klinik Und Poliklinik für Urologie und Kinder
Homburg / SAAR, 66421, Germany
Universitätsklinikum Lübeck Urologie
Lübeck, 23538, Germany
Universitätsklinikum Mannheim
Mannheim, 68135, Germany
Urologische Klinik Und Poliklinik Grosshadern
München, 81377, Germany
Klinikum Rechts Der Isar
München, 81675, Germany
Universitat Ulm
Ulm, 89070, Germany
Klinikum Wuppertal GmbH
Wuppertal, 42283, Germany
'Alexandra' Hospital
Athens, 115 27, Greece
Pe.Pa.G.N.I Hospital
Heraklion, 711 10, Greece
G. Genimatas Hospital
Thessaloniki, 546 35, Greece
Tallaght Hospital
Dublin, 24, Ireland
St Vincent'S Hospital
Dublin, 4, Ireland
Mater Misericordiae Hospital
Dublin, 7, Ireland
Clinica Urologica I - Università di Bari
Bari, 70124, Italy
Istituto Nazionale per la Ricerca sul Cancro -IST
Genoa, 16132, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Clinica Urologica - Università Di Milano
Milan, 20142, Italy
Istituto di Urologia
Padua, 35128, Italy
Policlinico G. B. Rossi
Verona, 37134, Italy
Amc
Amsterdam, 1105 AZ, Netherlands
Rijnstate Hospital
Arnhem, 6815 AD, Netherlands
Medisch Spectrun Twente
Enschede, 7500 KA, Netherlands
Atrium Heerlen
Heerlen, 6401 CX, Netherlands
University Hospital Rotterdam
Rotterdam, 3015 GD, Netherlands
St Franciscus Gasthuis
Rotterdam, 3045 PM, Netherlands
Canterbury Urology Research Trust
Christchurch, New Zealand
Promed Urology Ltd.
Tauranga, New Zealand
Samodzielny Publiczny ZOZ
Bydgoszcz, 85-168, Poland
Katedra i Klinika Urologii - Akademia Medyczna w Gdansku
Gdansk, 80-742, Poland
Specjalistyczny Szpital Urologiczny
Katowice, 40-073, Poland
Szpital Kliniczny Dzieciatka Jezus
Warsaw, 02-034, Poland
Instytut im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Akademia Medyczna we Wroclawiu
Wroclaw, 50-043, Poland
Mediclinic Hospital
Petermaritzburg, 3201, South Africa
University Of Stellenbosch
Cape Town, South Africa
University Of Natal - Nelson R Mandela School of Medicine
Durban, 4013, South Africa
Kenridge St Joseph Wingl
Parktown, 2010, South Africa
Medi-Clinic Hospital
Pietermaritzburg, 3201, South Africa
Medical Centre
Pietermaritzburg, 3201, South Africa
Pretoria Urology Hospital
Pretoria, 0083, South Africa
Hospital Juan Canalejo
A Coruña, 15006, Spain
Hospital de la Ribera
Alcira (Valencia), 46600, Spain
Hospital Vall D'Hebron
Barcelona, 08035, Spain
Hospital de Galdakao
Galdakao-Vizcaya, 48960, Spain
Clinica Puerta De Hierro
Madrid, 28035, Spain
Hospital 12 De Octubre
Madrid, 28041, Spain
Hospital Carlos Haya
Málaga, 29009, Spain
Hospital Marques De Valdecilla
Santander, 39008, Spain
Instituto Valenciano De Oncologia
Valencia, 46009, Spain
Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Linkoping University Hospital
Linköping, 501 85, Sweden
Lund University Hospital
Lund, 221 85, Sweden
Malmo University Hospital MAS
Malmo, 205 02, Sweden
Karolinska Hospital
Stockholm, 171 76, Sweden
Uppsala University Hospital
Uppsala, 751 85, Sweden
Royal Devon And Exeter Hospital
Exeter, Devon, EX2 5DW, United Kingdom
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Taunton And Somerset Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
The Institute Of Cancer Research - Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
St Lukes Hospital
Bradford, West Yorkshire, BD5 0NA, United Kingdom
Clatterbridge Centre For Oncology
Bebington, WIRRAL, CH63 4JY, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 2QQ, United Kingdom
St Richard'S Hospital
Chichester, PO19 4SE, United Kingdom
Leighton Hospital
Crewe, CW1 4QJ, United Kingdom
Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
Glasgow Royal Infirmary
Glasgow, G31 2ER, United Kingdom
St Batholomew'S Hospital
London, EC1A 7BE, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Clinical Research Centre - St Georges Hospital
London, SW17 0QT, United Kingdom
Hope Hospital
Salford, M6 8HD, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Southampton General
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gary Gordon, M.D.
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 10, 2002
First Posted
May 13, 2002
Study Start
June 1, 2001
Last Updated
August 15, 2007
Record last verified: 2007-08