CClinicalTrials.gg
CompletedNCT00036543Updated Aug 15, 2006

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

A Phase 3 interventional study of Atrasentan in Prostate Cancer, sponsored by Abbott. Completed at 233 sites in 18 countries. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2006-08-15.

Sponsored by Abbott · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
19 Years and older
Sex
Male
01

Study summary

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

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Hormone-Refractory, Prostate Cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 1,000 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,000 participants

Interventions

  • DrugAtrasentan
06

What researchers measure

Primary outcomes

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

07

Study locations

233 sites
  • 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
  • UCLA School Of Medicine
    Los Angeles,, California 90095-1738, United States
  • UCLA School of Medicine
    Los Angeles, California 90095-1738, 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
  • Urology Treatment Center
    Sarasota,, Florida 34239, United States
  • Southeastern Urological Center, P.A.
    Tallahassee, Florida 32308, United States
  • Winship Cancer Institute Emory University
    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
  • Weiss Memorial Hospital
    Chicago,, Illinois 60640, United States
  • Progressive Care, S.C.
    Chicago, Illinois 60631, United States
  • Evanston Hospital Kellogg Cancer Center
    Evanston, Illinois 60201, United States
  • Welborn Clinic
    Evansville, Indiana 47713, 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
  • Ochsner Clinic, Department of Urology
    New Orleans, Louisiana 70121, 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
  • Mid Atlantic Clinical Research
    Rockville, Maryland 20850, United States
  • Michigan Institute Of Urology, Pc
    St. Clair Shores, Michigan 48081, United States
  • Lakeside Urology, PC
    St. Joseph, Michigan 49085, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • The Medical Oncology Group
    Gulfport,, Mississippi 39501, United States
  • St. Joseph Oncology
    St. Joseph, Missouri 64507, United States
  • Washington University
    St. Louis, Missouri 63110, United States
  • Billings Oncology Associates
    Billings,, Montana 59101, United States
  • Nevada Urology Associate
    Reno, Nevada 89509, United States
  • Albany Medical Center South Clinical Campus
    Albany, New York 12208-3499, United States
  • Albert Einstein College of Medicine
    Bronx, New York 10461, 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
  • Rochester General Hospital
    Rochester, New York 14621, United States
  • St. Vincent's Medical Center - Staten Island
    Staten Island,, New York 10310, 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
  • The Urology Center
    Greensboro,, North Carolina 27401, 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
  • Vanderbilt University Medical Center
    Nashville,, Tennessee 37232-2765, United States
  • Urology Associates
    Nashville, Tennessee 37209, United States
  • Dept of Veteran's Affairs North Texas Healthcare System
    Dallas, Texas 75216, United States
  • Ntouch Research Corporation
    Dallas, Texas 75230, 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
  • Jeffrey Frankel, M.D.
    Seattle,, Washington 98166-3059, United States
  • Seattle Urological Associates
    Seattle, Washington 98104, United States
  • University Of Washington School Of Medicine
    Seattle, Washington 98109-1023, 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
  • St Vincent's Clinic
    Darlinghurst, New South Wales 2010, Australia
  • 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
  • Hollywood Specialist Centre
    Nedlands, Western Australia 6009, Australia
  • Princess Alexandra Hospital
    Woolloongabba, QLD 4102, Australia
  • Universitatsklinik Innsbruck
    Innsbruck, A-6020, Austria
  • Urologische Abteilung
    Linz, A-4010, Austria
  • Landesklinik fur Urologie und Andrologie
    Salzburg, A-5020, Austria
  • A.Z. Middelheim
    Antwerpen, 2020, Belgium
  • AZ Middelheim
    Antwerpen, 2020, Belgium
  • A Z St Jan
    Brugge, 8000, Belgium
  • University Hospital Erasme
    Bruxelles, 1070, Belgium
  • Uz Gent
    Gent, 9000, Belgium
  • Virga Jesse Hospital
    Hasselt, 3500, Belgium
  • C.H.U. Liege
    Liege, 4000, Belgium

Showing the first 100 of 233 sites across 18 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00036543
Lead sponsor
Abbott
First posted
May 13, 2002
Start date
May 2001
Last update
Aug 15, 2006

Study contacts

Darryl Sleep, M.D.
study director · Abbott
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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