AzTrials
AzTrials

Prostate CancerPhase 3NCT00036543

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

A Phase 3 study testing Atrasentan in people with Prostate Cancer, run by Abbott at 232 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 19 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Atrasentan
How many people
1,000 participants
Where
232 sitesin 18 countries
Study dates
May 2001to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of prostate cancer.
  • Rising PSA while on hormonal therapy or following surgical castration.
  • Documented evidence of metastatic disease.

Who cannot join

  • 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.

Trial locations and contacts

232 sites in 18 countries.

232 sites in 18 countries

United States79 sites

  • Albany Medical Center South Clinical Campus

    Albany, New York, 12208-3499

  • Urologic Associates of Allentown

    Allentown, Pennsylvania, 18103

  • Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99508

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • Sandy Springs Urology

    Atlanta, Georgia, 30328

  • Dreyer Medical Clinic

    Aurora, Illinois, 60506

  • South Fl Medical Research

    Aventura, Florida, 33180

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231-1000

  • Billings Oncology Associates

    Billings, Montana, 59101

  • HemOnCare, PC

    Brooklyn, New York, 11235

  • University Of Vermont

    Burlington, Vermont, 05403

  • The University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599-7235

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28203

  • Wyoming Research Foundation

    Cheyenne, Wyoming, 82001

  • Progressive Care, S.C.

    Chicago, Illinois, 60631

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Robin V. Smith, MD

    Chula Vista, California, 91910

  • Dept of Veteran's Affairs North Texas Healthcare System

    Dallas, Texas, 75216

  • Ntouch Research Corporation

    Dallas, Texas, 75230

  • Urologic Associates, Pc

    Davenport, Iowa, 52807

  • Atlanta Va Medical Center

    Decatur, Georgia, 30033

  • Urology Associate, Pc

    Denver, Colorado, 80210

  • Iowa Urology

    Des Moines, Iowa, 50309

  • Oregon Urology Specialists

    Eugene, Oregon, 97401

  • Evanston Hospital Kellogg Cancer Center

    Evanston, Illinois, 60201

  • Welborn Clinic

    Evansville, Indiana, 47713

  • Clinical Physiology Associates

    Fort Myers, Florida, 33916

  • Urology Associate Of Central California

    Fresno, California, 93720

  • South Valley Medical Plaza

    Gilroy, California, 95020-3535

  • The Urology Center

    Greensboro, North Carolina, 27401

  • The Medical Oncology Group

    Gulfport, Mississippi, 39501

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Urology Centers Of Alabama

    Homewood, Alabama, 35205

  • Kansas University Medical Center

    Kansas City, Kansas, 66160-7390

  • San Diego Urology Center

    La Mesa, California, 91942

  • Urological Associates Of Lancaster

    Lancaster, Pennsylvania, 17604-3200

  • Arkansas Urologial Associates, PA

    Little Rock, Arkansas, 72205

  • UCLA School Of Medicine

    Los Angeles, California, 90095-1738

  • Midwest Research Specialists, LLC

    Milwaukee, Wisconsin, 53209

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Urology Associates

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2765

  • Ochsner Clinic, Department of Urology

    New Orleans, Louisiana, 70121

  • Advanced Research Institute

    New Port Richey, Florida, 34652

  • Beth Israel Medical Center

    New York, New York, 10003

  • NYU Medical Center

    New York, New York, 10016

  • Nyack Hospital

    Nyack, New York, 10960

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Nevada Urology Associate

    Reno, Nevada, 89509

  • Virginia Urology Center

    Richmond, Virginia, 23230

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rochester General Hospital

    Rochester, New York, 14621

  • Mid Atlantic Clinical Research

    Rockville, Maryland, 20850

  • Michigan Institute Of Urology, Pc

    Saint Clair Shores, Michigan, 48081

  • Lakeside Urology, PC

    Saint Joseph, Michigan, 49085

  • St. Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Anthony Middleton, M.D.

    Salt Lake City, Utah, 84102

  • Western Urological Clinic

    Salt Lake City, Utah, 84107

  • Uthscsa

    San Antonio, Texas, 78229

  • Hillcrest Urological Medical Group, Inc.

    San Diego, California, 92103

  • Urology Associates Of San Luis Obispo

    San Luis Obispo, California, 93405

  • Pacific Clinical Research

    Santa Monica, California, 90404

  • Urology Treatment Center

    Sarasota, Florida, 34239

  • Seattle Urological Associates

    Seattle, Washington, 98104

  • University Of Washington School Of Medicine

    Seattle, Washington, 98109-1023

  • Jeffrey Frankel, M.D.

    Seattle, Washington, 98166-3059

  • Regional Urology

    Shreveport, Louisiana, 71106

  • LSUHSC

    Shreveport, Louisiana, 71130

  • Washington University

    St Louis, Missouri, 63110

  • St. Vincent's Medical Center - Staten Island

    Staten Island, New York, 10310

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Southeastern Urological Center, P.A.

    Tallahassee, Florida, 32308

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Western Clinical Research, Inc.

    Torrance, California, 90505-4763

  • Advanced Clinical Trials

    Tucson, Arizona, 85712

  • Urologic Specialists Of Oklahoma, Inc.

    Tulsa, Oklahoma, 74104-5433

  • Center for Urologic Care

    West Reading, Pennsylvania, 19611

Other trials in United States

Canada26 sites

  • The Male Health Centres

    Barrie, Ontario, L4M 4S5

  • Burlington Professional Centre

    Burlington, Ontario, L7N 3V2

  • The Urology Resource Centre

    Burlington, Ontario, L7S 1V2

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Service Radio-Oncologie, Chus

    Fleurimont, Quebec, J1H 5N4

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 2Y9

  • Wilson Urology

    Kelowna, British Columbia, V1Y 2H4

  • Valley Professional Centre

    Kentville, Nova Scotia, B4N 4K9

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Probidity Medical Research

    Kitchener, Ontario, N2M 5N6

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Quest Clinical Trials

    Markham, Ontario, L6B 1A1

  • Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Walk-In Clinic

    North Bay, Ontario, P1B 4Z2

  • Jack Barkin, M.D.

    North York, Ontario, M6A 3B5

  • The Male Health Centres

    Oakville, Ontario, L6H 3P1

  • Ultramed

    Pointe-Claire, Quebec, H9R 4S3

  • Chuq Pavillon Hotel-Dieu

    Québec, Quebec, G1R 2J6

  • Dr. Cal Andreou

    Surrey, British Columbia, V3V 1N1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Vancouver Hospital & Health Sciences Centre

    Vancouver, British Columbia, V5Z 3J5

  • Dr. P. J. Pommerville, Inc.

    Victoria, British Columbia, V8T5G1

  • Dr. Gary Steinhoff, Clinical Research

    Victoria, British Columbia, V8V 3N1

  • Abbott Clinic

    Winnipeg, Manitoba, R3C 1V8

Other trials in Canada

United Kingdom26 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB9 2ZB

  • Clatterbridge Centre For Oncology

    Bebington, WIRRAL, CH63 4JY

  • Institute Of Cancer Studies - University of Birmingham

    Birmingham, B15 2TT

  • St Lukes Hospital

    Bradford, West Yorkshire, BD5 0NA

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Southmead Hospital

    Bristol, BS10 5NB

  • Addenbrookes Hospital

    Cambridge, CB2 2QQ

  • St Richard'S Hospital

    Chichester, PO19 4SE

  • Leighton Hospital

    Crewe, CW1 4QJ

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Royal Devon And Exeter Hospital

    Exeter, Devon, EX2 5DW

  • Gartnavel General Hospital

    Glasgow, G12 0YN

  • Glasgow Royal Infirmary

    Glasgow, G31 2ER

  • Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ

  • Freeman Hospital

    High Heaton, NE7 7HH

  • St Batholomew'S Hospital

    London, EC1A 7BE

  • Royal Free Hospital

    London, NW3 2QG

  • Clinical Research Centre - St Georges Hospital

    London, SW17 0QT

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Derriford Hospital

    Plymouth, PL6 8 DH

  • Hope Hospital

    Salford, M6 8HD

  • Royal Hallamshire Hospital

    Sheffield, S10 1JF

  • Southampton General

    Southampton, SO16 6YD

  • Lister Hospital

    Stevenage, Hertfordshire, SG1 4AB

  • The Institute Of Cancer Research - Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • Taunton And Somerset Hospital

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Germany15 sites

  • Krankenhaus Am Urban

    Berlin, 10967

  • Allgemeines Krankenhaus Urologie

    Celle, 29223

  • Universitätsklinikum Carl Gustav Carus an der

    Dresden, 01307

  • Universitätsklinikum Urologie

    Essen, 45147

  • Universitätsklinkum

    Freiburg im Breisgau, 79106

  • Allgemeines Krankenhaus Barmbek

    Hamburg, 22291

  • Klinik Und Poliklinik für Urologie und Kinder

    Homburg / SAAR, 66421

  • Universitutsklinikum Lubeck Urologie

    Lübeck, 23538

  • Universitätsklinikum Mannheim

    Mannheim, 68135

  • Urologische Klinik Und Poliklinik Grosshadern

    München, 81377

  • Klinikum Rechts Der Isar

    München, 81675

  • Universitätsklinikum

    Münster, 48129

  • Städtische Kliniken, Urologie

    Offenbach, 63069

  • Universitat Ulm

    Ulm, 89070

  • Klinikum Wuppertal GmbH

    Wuppertal, 42283

Other trials in Germany

Australia10 sites

  • St Vincent's Clinic

    Darlinghurst, New South Wales, 2010

  • Repatriation General Hospital

    Daws Park, South Australia, 5041

  • Peter Maccallum Cancer Institute

    East Melbourne, Victoria, 3002

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Bayside Urology

    Mentone, Victoria, 3194

  • Hollywood Specialist Centre

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Prince Of Wales Hospital

    Randwick, New South Wales, 2031

  • Westmead Public Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102

Other trials in Australia

Spain10 sites

  • Hospital Juan Canalejo

    A Coruña, 15006

  • Fundacion Puigvert

    Barcelona, 08025

  • Hospital Vall D'Hebron

    Barcelona, 08035

  • Hospital de Galdakao

    Galdakao-Vizcaya, 48960

  • Hospital Gregorio Maranon

    Madrid, 28007

  • Clinica Puerta De Hierro

    Madrid, 28035

  • Hospital 12 De Octubre

    Madrid, 28041

  • Hospital Carlos Haya

    Málaga, 29009

  • Hospital Marques De Valdecilla

    Santander, 39008

  • Instituto Valenciano De Oncologia

    Valencia, 46009

Other trials in Spain

South Africa9 sites

  • Constantiaberg Medi-Clinic

    Cape Town, 7081

  • University Of Stellenbosch

    Cape Town

  • University Of Natal - Nelson R Mandela School of Medicine

    Durban, 4013

  • Kenridge St Joseph Wingl

    Parktown, 2010

  • Mediclinic Hospital

    Petermaritzburg, 3201

  • Medi-Clinic Hospital

    Pietermaritzburg, 3201

  • Medical Centre

    Pietermaritzburg, 3201

  • Pretoria Urology Hospital

    Pretoria, 0083

  • Pretoria Academic Hospital

    Pretoria

Other trials in South Africa

Sweden9 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Helsingborg Hospital

    Helsingborg, 251 87

  • Linkoping University Hospital

    Linköping, 501 85

  • Lund University Hospital

    Lund, 221 85

  • Malmo University Hospital MAS

    Malmö, 205 02

  • Orebro Regional Hospital

    Örebro, 701 85

  • Karolinska Hospital

    Stockholm, 171 76

  • Umea University Hospital

    Umeå, 901 85

  • Uppsala University Hospital

    Uppsala, 751 85

Other trials in Sweden

Belgium8 sites

  • A.Z. Middelheim

    Antwerp, 2020

  • AZ Middelheim

    Antwerp, 2020

  • A Z St Jan

    Bruges, 8000

  • University Hospital Erasme

    Brussels, 1070

  • Uz Gent

    Ghent, 9000

  • Virga Jesse Hospital

    Hasselt, 3500

  • C.H.U. Liege

    Liège, 4000

  • St-Elisabeth Ziekenhuis

    Turnhout, 2300

Other trials in Belgium

Netherlands8 sites

  • Amc

    Amsterdam, 1105 AZ

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Medisch Spectrun Twente

    Enschede, 7500 KA

  • Atrium Heerlen

    Heerlen, 6401 CX

  • University Hospital Maastricht

    Maastricht, 6229 HX

  • University Hospital Rotterdam

    Rotterdam, 3015 GD

  • St Franciscus Gasthuis

    Rotterdam, 3045 PM

  • University Hospital Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

France7 sites

  • CHU Hôpital Côte De Nacre

    Caen, 14033

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • Hopital De Pontchaillou

    Rennes, Cedex, 35033

  • Hôpital Foch

    Suresnes, 92151

  • Hopital De Rangueil

    Toulouse, Cedex, 31043

Other trials in France

Italy6 sites

  • Clinica Urologica I - Università di Bari

    Bari, 70124

  • Istituto Nazionale per la Ricerca sul Cancro -IST

    Genoa, 16132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Clinica Urologica - Università Di Milano

    Milan, 20142

  • Istituto di Urologia

    Padova, 35128

  • Policlinico G. B. Rossi

    Verona, 37134

Other trials in Italy

Poland5 sites

  • Katedra I Klinika Urologi AM

    Gdansk, 80-742

  • Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

    Gdansk, 80-742

  • Samodzielny Publiczny Zaklad Opieki

    Katowice, 40-073

  • Szpital Kliniczny Dzieciatka Jezus

    Warsaw, 02-034

  • Akademia Medyczna we Wroclawiu

    Wroclaw, 50-043

Other trials in Poland

Austria3 sites

  • Universitatsklinik Innsbruck

    Innsbruck, A-6020

  • Urologische Abteilung

    Linz, A-4010

  • Landesklinik fur Urologie und Andrologie

    Salzburg, A-5020

Other trials in Austria

Greece3 sites

  • 'Alexandra' Hospital

    Athens, 115 27

  • Pe.Pa.G.N.I Hospital

    Heraklion, 711 10

  • G. Genimatas Hospital

    Thessaloniki, 546 35

Other trials in Greece

Ireland3 sites

  • Tallaght Hospital

    Dublin, 24

  • St Vincent'S Hospital

    Dublin, 4

  • Mater Misericordiae Hospital

    Dublin, 7

Other trials in Ireland

Switzerland3 sites

  • Zentrum fur Onkologie, Hämatologie und

    Aarau, 5001

  • Inselspital, Universität Bern

    Bern, 3010

  • Chefarzt Urologische Klinik - Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

New Zealand2 sites

  • Canterbury Urology Research Trust

    Christchurch

  • Promed Urology Ltd.

    Tauranga

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

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

Conditions
Prostate Cancer
Being tested
Atrasentan
Keywords
Hormone-Refractory, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtrasentanDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2002 (estimated)
  2. Study startMay 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036543
Sponsor's protocol ID
M00-211
Status last verified
Aug 2006
First submitted
10 May 2002
Last updated
15 Aug 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atrasentan in people with Prostate Cancer, run by Abbott at 232 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, Canada, United Kingdom, Germany, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00036543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2006.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in