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Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00038662
Recruitment Status : Completed
First Posted : June 4, 2002
Last Update Posted : August 15, 2006
Sponsor:
Information provided by:
Abbott

Brief Summary:
The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Atrasentan Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
Study Start Date : May 2002

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Primary Outcome Measures :
  1. Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prostate adenocarcinoma,
  • radical prostatectomy,
  • PSA between 0.4 and 5 ng/mL,
  • PSADT < 1 year

Exclusion Criteria:

  • previous hormonal therapy,
  • salvage therapy to the pelvis within 3 months prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038662


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Locations
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United States, Alabama
Urology Centers Of Alabama
Homewood,, Alabama, United States, 35205
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Urologial Associates, PA
Little Rock, Arkansas, United States, 72205
United States, California
San Diego Urology Center
La Mesa, California, United States, 91942
Western Clinical Research Inc
Torrance, California, United States, 90505
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Clinical Physiology Associates
Fort Myers, Florida, United States, 33916
Southeastern Urological Center, PA
Tallahassee, Florida, United States, 32308
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-1000
United States, Nevada
Sheldon Freedman MD
Las Vegas, Nevada, United States, 89109
VA Medical Center(111)
Reno, Nevada, United States, 89502
Nevada Urology Associates
Reno, Nevada, United States, 89511
United States, North Carolina
Carolinas Medical Centre
Charlotte,, North Carolina, United States, 28204
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Urologic Specialists Of Oklahoma, Inc.
Tulsa,, Oklahoma, United States, 74104-5433
United States, Oregon
Oregon Urology Specialists
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Urological Assoc. of Lancaster
Lancaster, Pennsylvania, United States, 17604-3200
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Center for Urologic Care
West Reading,, Pennsylvania, United States, 19611
Center for Urologic Care
West Reading, Pennsylvania, United States, 19611
United States, Texas
Ntouch Research Corporation
Dallas, Texas, United States, 75230
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
United States, Washington
Jeffrey Frankel, M.D.
Seattle,, Washington, United States, 98166-3059
University of Washington Medical Center
Seattle, Washington, United States, 98195
Canada, Alberta
Tom Baker Cancer Center
Calgary,, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Canada, British Columbia
Cal Andreou, MD
Surrey, British Columbia, Canada, V3V 1N1
Can-Med Medical Research Inc
Victoria, British Columbia, Canada
Canada, Nova Scotia
Bruce W. Palmer Urology Inc.
Kentville, Nova Scotia, Canada, B4N4K9
Canada, Ontario
The Male Health Centres
Barrie, Ontario, Canada, L4M 4S5
Burlington Professional Centre
Burlington, Ontario, Canada, L7N 3V2
Hamilton & District Urology Association
Hamilton,, Ontario, Canada, L8N 1T8
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Quest Clinical Trials
Markham, Ontario, Canada, L6B1A1
Guardian Medical Arts Bldg.
North Bay, Ontario, Canada, P1B4Z2
Jack Barkin, MD
North York, Ontario, Canada, M6A 3B5
The Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
Sunnybrook &Women's College Health Sciens Center
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Canada
Chuq Pavillon Hotel-Dieu
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Darryl Sleep, M.D. Abbott

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ClinicalTrials.gov Identifier: NCT00038662     History of Changes
Obsolete Identifiers: NCT00084994
Other Study ID Numbers: M01-366
First Posted: June 4, 2002    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Atrasentan
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action