Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
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
1 other identifier
interventional
200
2 countries
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 3, 2002
CompletedFirst Posted
Study publicly available on registry
June 4, 2002
CompletedAugust 15, 2006
August 1, 2006
June 3, 2002
August 10, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Interventions
Eligibility Criteria
You may qualify if:
- prostate adenocarcinoma,
- radical prostatectomy,
- PSA between 0.4 and 5 ng/mL,
- PSADT \< 1 year
You may not qualify if:
- previous hormonal therapy,
- salvage therapy to the pelvis within 3 months prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (40)
Urology Centers Of Alabama
Homewood, Alabama, 35205, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Arkansas Urologial Associates, PA
Little Rock, Arkansas, 72205, United States
San Diego Urology Center
La Mesa, California, 91942, United States
Western Clinical Research Inc
Torrance, California, 90505, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
Southeastern Urological Center, PA
Tallahassee, Florida, 32308, United States
Northwestern University
Chicago, Illinois, 60611, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-1000, United States
Sheldon Freedman MD
Las Vegas, Nevada, 89109, United States
VA Medical Center(111)
Reno, Nevada, 89502, United States
Nevada Urology Associates
Reno, Nevada, 89511, United States
Carolinas Medical Centre
Charlotte, North Carolina, 28204, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Urologic Specialists Of Oklahoma, Inc.
Tulsa, Oklahoma, 74104-5433, United States
Oregon Urology Specialists
Eugene, Oregon, 97401, United States
Urological Assoc. of Lancaster
Lancaster, Pennsylvania, 17604-3200, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Center for Urologic Care
West Reading, Pennsylvania, 19611, United States
Ntouch Research Corporation
Dallas, Texas, 75230, United States
Salt Lake Research
Salt Lake City, Utah, 84124, United States
Jeffrey Frankel, M.D.
Seattle, Washington, 98166-3059, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
Cal Andreou, MD
Surrey, British Columbia, V3V 1N1, Canada
Can-Med Medical Research Inc
Victoria, British Columbia, Canada
Bruce W. Palmer Urology Inc.
Kentville, Nova Scotia, B4N4K9, Canada
The Male Health Centres
Barrie, Ontario, L4M 4S5, Canada
Burlington Professional Centre
Burlington, Ontario, L7N 3V2, Canada
Hamilton & District Urology Association
Hamilton, Ontario, L8N 1T8, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Quest Clinical Trials
Markham, Ontario, L6B1A1, Canada
Guardian Medical Arts Bldg.
North Bay, Ontario, P1B4Z2, Canada
Jack Barkin, MD
North York, Ontario, M6A 3B5, Canada
The Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Sunnybrook &Women's College Health Sciens Center
Toronto, Ontario, M4N 3M5, Canada
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Chuq Pavillon Hotel-Dieu
Québec, Quebec, G1R 2J6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Darryl Sleep, M.D.
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2002
First Posted
June 4, 2002
Study Start
May 1, 2002
Last Updated
August 15, 2006
Record last verified: 2006-08