AzTrials
AzTrials

Prostatic NeoplasmsPhase 3NCT00036556

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

A Phase 3 study testing Atrasentan in people with Prostatic Neoplasms, run by Abbott at 234 sites in 17 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 non-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
Prostatic Neoplasms
What is being tested?
Atrasentan
How many people
941 participants
Where
234 sitesin 17 countries
Study dates
Jun 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

  • Have been diagnosed with prostate cancer.
  • Have a rising PSA while on hormone therapy or following surgical castration.

Who cannot join

  • 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.

Trial locations and contacts

234 sites in 17 countries.

234 sites in 17 countries

United States94 sites

  • Albany Medical Center South Clinical Campus

    Albany, New York, 12208-3499

  • UNM Medical Center

    Albuquerque, New Mexico, 87131

  • Urologic Associates of Allentown

    Allentown, Pennsylvania, 18103

  • Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99508

  • Peachtree Hematology/Oncology Consultants

    Atlanta, Georgia, 30309

  • Emory Clinic

    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

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2617

  • 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

  • Mckay Urology

    Charlotte, North Carolina, 28204

  • Urology Specialists Of The Carolinas

    Charlotte, North Carolina, 28207

  • Wyoming Research Foundation

    Cheyenne, Wyoming, 82001

  • Northwestern University Medical School

    Chicago, Illinois, 60611-3010

  • Progressive Care, S.C.

    Chicago, Illinois, 60631

  • Christopher Ryan, MD

    Chicago, Illinois, 60637-1470

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Robin V. Smith, MD

    Chula Vista, California, 91910

  • University Of Cincinnati Medical Center

    Cincinnati, Ohio, 45267-0589

  • Dept of Veteran's Affairs North Texas Healthcare System

    Dallas, Texas, 75216

  • Ntouch Research Corporation

    Dallas, Texas, 75230

  • The University Of TX SW Medical Center At Dallas

    Dallas, Texas, 75390-9110

  • 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

  • Welborn Clinic -East

    Evansville, Indiana, 47714-0981

  • Clinical Physiology Associates

    Fort Myers, Florida, 33916

  • Urology Associate Of Central California

    Fresno, California, 93720

  • South Valley Medical Plaza

    Gilroy, California, 95020-3535

  • Michigan Medical Urology

    Grand Rapids, Michigan, 49503

  • Drs. Werner, Murdock, & Francis, Pa Urology Assoc.

    Greenbelt, Maryland, 20770

  • 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

  • Mississippi Center For Clinical Research, LLC

    Jackson, Mississippi, 39216

  • Kansas University Medical Center

    Kansas City, Kansas, 66160-7390

  • San Diego Urology Center

    La Mesa, California, 91942

  • South Orange County Medical Research Center

    Laguna Hills, California, 92653

  • 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

  • University of TN - Memphis

    Memphis, Tennessee, 38104

  • 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

  • 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

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7860

  • VA Palo Alto

    Palo Alto, California, 94304

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Multimed Research

    Providence, Rhode Island, 02905

  • Nevada Urology Associate

    Reno, Nevada, 89509

  • Virginia Urology Center

    Richmond, Virginia, 23230

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • 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

  • Dattoli Cancer Center

    Sarasota, Florida, 34237

  • 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

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Southeastern Urological Center, P.A.

    Tallahassee, Florida, 32308

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • 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

Canada32 sites

  • The Male Health Centres

    Barrie, Ontario, L4M 4S5

  • 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

  • Professional Corporation

    Fredericton, New Brunswick, E3B 5B8

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 2Y9

  • Hamilton & District Urology Association

    Hamilton, Ontario, L8N 1T8

  • 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

  • Ottawa Hospital Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Ultramed

    Pointe-Claire, Quebec, H9R 4S3

  • Chuq Pavillon Hotel-Dieu

    Québec, Quebec, G1R 2J6

  • Peter Lau, MD

    Saskatoon, Saskatchewan, S7K 3H3

  • Advanced Male Fertility Clinic

    Scarborough Village, Ontario, M1S 4V5

  • Dr. Cal Andreou

    Surrey, British Columbia, V3V 1N1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • 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 Kingdom20 sites

  • Clatterbridge Centre For Oncology

    Bebington, WIRRAL, CH63 4JY

  • St Lukes Hospital

    Bradford, West Yorkshire, BD5 0NA

  • 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

  • St Batholomew'S Hospital

    London, EC1A 7BE

  • Royal Free Hospital

    London, NW3 2QG

  • Clinical Research Centre - St Georges Hospital

    London, SW17 0QT

  • Hope Hospital

    Salford, M6 8HD

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • 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

Germany12 sites

  • Allgemeines Krankenhaus Urologie

    Celle, 29223

  • Universitätsklinikum Urologie

    Essen, 45147

  • Universitätsklinkum

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Allgemeines Krankenhaus Barmbek

    Hamburg, 22291

  • Klinik Und Poliklinik für Urologie und Kinder

    Homburg / SAAR, 66421

  • Universitätsklinikum Lübeck Urologie

    Lübeck, 23538

  • Universitätsklinikum Mannheim

    Mannheim, 68135

  • Urologische Klinik Und Poliklinik Grosshadern

    München, 81377

  • Klinikum Rechts Der Isar

    München, 81675

  • Universitat Ulm

    Ulm, 89070

  • Klinikum Wuppertal GmbH

    Wuppertal, 42283

Other trials in Germany

France11 sites

  • Hôpital D´Auxerre

    Auxerre, 89000

  • Hopital Intercommunal

    Créteil, Cedex, 94010

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital Salvator

    Marseille, Cedex, 9 13274

  • Hôpital Pasteur

    Nice, Cedex, 3 06202

  • Hôpital Cochin

    Paris, Cedex 14, 75679

  • Hôpital Saint Louis

    Paris, Cedex, 10 75475

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • Centre Hospitalier Rene Dubos

    Pontoise, Cedex, 95303

  • Hopital De Pontchaillou

    Rennes, Cedex, 35033

  • Hopital De Rangueil

    Toulouse, Cedex, 31043

Other trials in France

Spain9 sites

  • Hospital Juan Canalejo

    A Coruña, 15006

  • Hospital de la Ribera

    Alcira (Valencia), 46600

  • Hospital Vall D'Hebron

    Barcelona, 08035

  • Hospital de Galdakao

    Galdakao-Vizcaya, 48960

  • 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

Australia8 sites

  • 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

  • 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

Belgium7 sites

  • A.Z. Middelheim

    Antwerp, 2020

  • A Z St Jan

    Bruges, 8000

  • University Hospital Erasme

    Brussels, 1070

  • Uz Gent

    Ghent, 9000

  • Private Practice Dr.Vekemans

    Hasselt, 3500

  • C.H.U. Liege

    Liège, 4000

  • St-Elisabeth Ziekenhuis

    Turnhout, 2300

Other trials in Belgium

South Africa7 sites

  • 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

Other trials in South Africa

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

Netherlands6 sites

  • Amc

    Amsterdam, 1105 AZ

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Medisch Spectrun Twente

    Enschede, 7500 KA

  • Atrium Heerlen

    Heerlen, 6401 CX

  • University Hospital Rotterdam

    Rotterdam, 3015 GD

  • St Franciscus Gasthuis

    Rotterdam, 3045 PM

Other trials in Netherlands

Poland6 sites

  • Samodzielny Publiczny ZOZ

    Bydgoszcz, 85-168

  • Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

    Gdansk, 80-742

  • Specjalistyczny Szpital Urologiczny

    Katowice, 40-073

  • Szpital Kliniczny Dzieciatka Jezus

    Warsaw, 02-034

  • Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Akademia Medyczna we Wroclawiu

    Wroclaw, 50-043

Other trials in Poland

Sweden6 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Linkoping University Hospital

    Linköping, 501 85

  • Lund University Hospital

    Lund, 221 85

  • Malmo University Hospital MAS

    Malmö, 205 02

  • Karolinska Hospital

    Stockholm, 171 76

  • Uppsala University Hospital

    Uppsala, 751 85

Other trials in Sweden

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

Austria2 sites

  • A. Ö. Krankenhaus Mistelbach

    Mistelbach, 2130

  • Klinik fur Urologie der Universitat Wien

    Vienna, A-1090

Other trials in Austria

New Zealand2 sites

  • Canterbury Urology Research Trust

    Christchurch

  • Promed Urology Ltd.

    Tauranga

Other trials in New Zealand

About this study

Official title: 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.

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. 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.

    Measured: Every 12 weeks

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 startJun 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
941 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036556
Sponsor's protocol ID
M00-244
Status last verified
Aug 2007
First submitted
10 May 2002
Last updated
15 Aug 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atrasentan in people with Prostatic Neoplasms, run by Abbott at 234 sites in 17 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 2 inclusion and 3 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 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in United States, Canada, United Kingdom, Germany, France and 12 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?

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). 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 NCT00036556.

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 2007.

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