Clinical trial NCT00036556: Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Official title: A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Hormone-Refractory Prostate Cancer
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-05-13
Enrollment: 941
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Every 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood,
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Tucson
country: United States
facility: Advanced Clinical Trials
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urologial Associates, PA
state: Arkansas
city: Chula Vista
country: United States
facility: Robin V. Smith, MD
state: California
city: Fresno,
country: United States
facility: Urology Associate Of Central California
state: California
city: Gilroy
country: United States
facility: South Valley Medical Plaza
state: California
city: La Mesa
country: United States
facility: San Diego Urology Center
state: California
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
city: San Diego
country: United States
facility: Hillcrest Urological Medical Group, Inc.
state: California
city: San Luis Obispo,
country: United States
facility: Urology Associates Of San Luis Obispo
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Torrance,
country: United States
facility: Western Clinical Research, Inc.
state: California
city: Denver,
country: United States
facility: Urology Associate, Pc
state: Colorado
city: Aventura
country: United States
facility: South Fl Medical Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Sarasota,
country: United States
facility: Dattoli Cancer Center
state: Florida
city: Sarasota,
country: United States
facility: Urology Treatment Center
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Urological Center, P.A.
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology/Oncology Consultants
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Sandy Springs Urology
state: Georgia
city: Decatur
country: United States
facility: Atlanta Va Medical Center
state: Georgia
city: Aurora
country: United States
facility: Dreyer Medical Clinic
state: Illinois
city: Chicago,
country: United States
facility: Weiss Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Chicago
country: United States
facility: Progressive Care, S.C.
state: Illinois
city: Chicago
country: United States
facility: Christopher Ryan, MD
state: Illinois
city: Evanston
country: United States
facility: Evanston Hospital Kellogg Cancer Center
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Evansville
country: United States
facility: Welborn Clinic -East
state: Indiana
city: Davenport
country: United States
facility: Urologic Associates, Pc
state: Iowa
city: Des Moines
country: United States
facility: Iowa Urology
state: Iowa
city: Kansas City,
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Shreveport
country: United States
facility: LSUHSC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Greenbelt
country: United States
facility: Drs. Werner, Murdock, & Francis, Pa Urology Assoc.
state: Maryland
city: Rockville
country: United States
facility: Mid Atlantic Clinical Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Michigan Medical Urology
state: Michigan
city: St. Clair Shores
country: United States
facility: Michigan Institute Of Urology, Pc
state: Michigan
city: St. Joseph
country: United States
facility: Lakeside Urology, PC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Gulfport,
country: United States
facility: The Medical Oncology Group
state: Mississippi
city: Jackson
country: United States
facility: Mississippi Center For Clinical Research, LLC
state: Mississippi
city: St. Joseph
country: United States
facility: St. Joseph Oncology
state: Missouri
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Billings,
country: United States
facility: Billings Oncology Associates
state: Montana
city: Omaha,
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Reno
country: United States
facility: Nevada Urology Associate
state: Nevada
city: Albuquerque
country: United States
facility: UNM Medical Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center South Clinical Campus
state: New York
city: Brooklyn
country: United States
facility: HemOnCare, PC
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Nyack
country: United States
facility: Nyack Hospital
state: New York
city: Chapel Hill
country: United States
facility: The University Of North Carolina At Chapel Hill
state: North Carolina
city: Charlotte,
country: United States
facility: Mckay Urology
state: North Carolina
city: Charlotte,
country: United States
facility: Urology Specialists Of The Carolinas
state: North Carolina
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Greensboro,
country: United States
facility: The Urology Center
state: North Carolina
city: Cincinnati,
country: United States
facility: University Of Cincinnati Medical Center
state: Ohio
city: Tulsa,
country: United States
facility: Urologic Specialists Of Oklahoma, Inc.
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Urology Specialists
state: Oregon
city: Allentown
country: United States
facility: Urologic Associates of Allentown
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Urological Associates Of Lancaster
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Of Pittsburgh
state: Pennsylvania
city: West Reading,
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: Providence,
country: United States
facility: Multimed Research
state: Rhode Island
city: Memphis
country: United States
facility: University of TN - Memphis
state: Tennessee
city: Nashville,
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Dallas
country: United States
facility: Dept of Veteran's Affairs North Texas Healthcare System
state: Texas
city: Dallas
country: United States
facility: Ntouch Research Corporation
state: Texas
city: Dallas
country: United States
facility: The University Of TX SW Medical Center At Dallas
state: Texas
city: San Antonio
country: United States
facility: Uthscsa
state: Texas
city: Temple,
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Salt Lake City,
country: United States
facility: Anthony Middleton, M.D.
state: Utah
city: Salt Lake City
country: United States
facility: Western Urological Clinic
state: Utah
city: Burlington,
country: United States
facility: University Of Vermont
state: Vermont
city: Richmond,
country: United States
facility: Virginia Urology Center
state: Virginia
city: Seattle,
country: United States
facility: Jeffrey Frankel, M.D.
state: Washington
city: Seattle
country: United States
facility: Seattle Urological Associates
state: Washington
city: Seattle
country: United States
facility: University Of Washington School Of Medicine
state: Washington
city: Tacoma,
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Midwest Research Specialists, LLC
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Cheyenne
country: United States
facility: Wyoming Research Foundation
state: Wyoming
city: Randwick
country: Australia
facility: Prince Of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Public Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Daws Park
country: Australia
facility: Repatriation General Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Peter Maccallum Cancer Institute
state: Victoria
city: Mentone
country: Australia
facility: Bayside Urology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Mistelbach
country: Austria
facility: A. Ö. Krankenhaus Mistelbach
city: Wien
country: Austria
facility: Klinik fur Urologie der Universitat Wien
city: Antwerpen
country: Belgium
facility: A.Z. Middelheim
city: Brugge
country: Belgium
facility: A Z St Jan
city: Bruxelles
country: Belgium
facility: University Hospital Erasme
city: Gent
country: Belgium
facility: Uz Gent
city: Hasselt
country: Belgium
facility: Private Practice Dr.Vekemans
city: Liege
country: Belgium
facility: C.H.U. Liege
city: Turnhout
country: Belgium
facility: St-Elisabeth Ziekenhuis
city: Calgary,
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton,
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: Wilson Urology
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Cal Andreou
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Hospital & Health Sciences Centre
state: British Columbia
city: Victoria
country: Canada
facility: Dr. P. J. Pommerville, Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Gary Steinhoff, Clinical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Abbott Clinic
state: Manitoba
city: Fredericton
country: Canada
facility: Professional Corporation
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Kentville
country: Canada
facility: Valley Professional Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male Health Centres
state: Ontario
city: Burlington
country: Canada
facility: The Urology Resource Centre
state: Ontario
city: Hamilton,
country: Canada
facility: Hamilton & District Urology Association
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Probidity Medical Research
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Markham
country: Canada
facility: Quest Clinical Trials
state: Ontario
city: North Bay
country: Canada
facility: Walk-In Clinic
state: Ontario
city: North York
country: Canada
facility: Jack Barkin, M.D.
state: Ontario
city: Oakville
country: Canada
facility: The Male Health Centres
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Civic Campus
state: Ontario
city: Scarborough,
country: Canada
facility: Advanced Male Fertility Clinic
state: Ontario
city: Sudbury,
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Fleurimont,
country: Canada
facility: Service Radio-Oncologie, Chus
state: Quebec
city: Montreal
country: Canada
facility: Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Pointe Claire
country: Canada
facility: Ultramed
state: Quebec
city: Saskatoon,
country: Canada
facility: Peter Lau, MD
state: Saskatchewan
city: Quebec
country: Canada
facility: Chuq Pavillon Hotel-Dieu
city: Paris
country: France
facility: Hôpital Cochin
state: Cedex 14
city: Creteil
country: France
facility: Hopital Intercommunal
state: Cedex
city: Marseille
country: France
facility: Hôpital Salvator
state: Cedex
city: Nice
country: France
facility: Hôpital Pasteur
state: Cedex
city: Paris
country: France
facility: Hôpital Saint Louis
state: Cedex
city: Pontoise
country: France
facility: Centre Hospitalier Rene Dubos
state: Cedex
city: Rennes
country: France
facility: Hopital De Pontchaillou
state: Cedex
city: Toulouse
country: France
facility: Hopital De Rangueil
state: Cedex
city: Auxerre
country: France
facility: Hôpital D´Auxerre
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Urologie
city: Essen
country: Germany
facility: Universitätsklinikum Urologie
city: Freiburg
country: Germany
facility: Universitätsklinkum
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Barmbek
city: Homburg / Saar
country: Germany
facility: Klinik Und Poliklinik für Urologie und Kinder
city: Lübeck
country: Germany
facility: Universitätsklinikum Lübeck Urologie
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Munchen
country: Germany
facility: Urologische Klinik Und Poliklinik Grosshadern
city: Munchen
country: Germany
facility: Klinikum Rechts Der Isar
city: ULM
country: Germany
facility: Universitat Ulm
city: Wuppertal
country: Germany
facility: Klinikum Wuppertal GmbH
city: Athens
country: Greece
facility: 'Alexandra' Hospital
city: Heraklion
country: Greece
facility: Pe.Pa.G.N.I Hospital
city: Thessaloniki
country: Greece
facility: G. Genimatas Hospital
city: Dublin
country: Ireland
facility: Tallaght Hospital
city: Dublin
country: Ireland
facility: St Vincent'S Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
city: Bari
country: Italy
facility: Clinica Urologica I - Università di Bari
city: Genoa
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro -IST
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: Clinica Urologica - Università Di Milano
city: Padova
country: Italy
facility: Istituto di Urologia
city: Verona
country: Italy
facility: Policlinico G. B. Rossi
city: Amsterdam
country: Netherlands
facility: Amc
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrun Twente
city: Heerlen
country: Netherlands
facility: Atrium Heerlen
city: Rotterdam
country: Netherlands
facility: University Hospital Rotterdam
city: Rotterdam
country: Netherlands
facility: St Franciscus Gasthuis
city: Christchurch
country: New Zealand
facility: Canterbury Urology Research Trust
city: Tauranga
country: New Zealand
facility: Promed Urology Ltd.
city: Bydgoszcz
country: Poland
facility: Samodzielny Publiczny ZOZ
city: Gdansk
country: Poland
facility: Katedra i Klinika Urologii - Akademia Medyczna w Gdansku
city: Katowice
country: Poland
facility: Specjalistyczny Szpital Urologiczny
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus
city: Warszawa
country: Poland
facility: Instytut im. Marii Sklodowskiej-Curie
city: Wroclaw
country: Poland
facility: Akademia Medyczna we Wroclawiu
city: Petermaritzburg
country: South Africa
facility: Mediclinic Hospital
state: 3201
city: Cape Town
country: South Africa
facility: University Of Stellenbosch
city: Durban
country: South Africa
facility: University Of Natal - Nelson R Mandela School of Medicine
city: Parktown
country: South Africa
facility: Kenridge St Joseph Wingl
city: Pietermaritzburg
country: South Africa
facility: Medi-Clinic Hospital
city: Pietermaritzburg
country: South Africa
facility: Medical Centre
city: Pretoria
country: South Africa
facility: Pretoria Urology Hospital
city: Alcira (Valencia)
country: Spain
facility: Hospital de la Ribera
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Galdakao-Vizcaya
country: Spain
facility: Hospital de Galdakao
city: La Coruna
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Clinica Puerta De Hierro
city: Madrid
country: Spain
facility: Hospital 12 De Octubre
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Santander
country: Spain
facility: Hospital Marques De Valdecilla
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
city: Malmo
country: Sweden
facility: Malmo University Hospital MAS
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Exeter,
country: United Kingdom
facility: Royal Devon And Exeter Hospital
state: Devon
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Hertfordshire
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: Edinburgh,
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Taunton
country: United Kingdom
facility: Taunton And Somerset Hospital
state: Somerset
city: Sutton
country: United Kingdom
facility: The Institute Of Cancer Research - Royal Marsden Hospital
state: Surrey
city: Bradford
country: United Kingdom
facility: St Lukes Hospital
state: West Yorkshire
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre For Oncology
state: Wirral
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Chichester
country: United Kingdom
facility: St Richard'S Hospital
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: London
country: United Kingdom
facility: St Batholomew'S Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Clinical Research Centre - St Georges Hospital
city: Salford
country: United Kingdom
facility: Hope Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Southampton
country: United Kingdom
facility: Southampton General
Study officials:
affiliation: Abbott
name: Gary Gordon, M.D.
role: STUDY_DIRECTOR
References: