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Brief Title: Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
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 ID: NCT00038662
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).
Detailed Description:
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Urology Centers Of Alabama, Homewood,, Alabama, United States
Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States
Arkansas Urologial Associates, PA, Little Rock, Arkansas, United States
San Diego Urology Center, La Mesa, California, United States
Western Clinical Research Inc, Torrance, California, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Clinical Physiology Associates, Fort Myers, Florida, United States
Southeastern Urological Center, PA, Tallahassee, Florida, United States
Northwestern University, Chicago, Illinois, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Sheldon Freedman MD, Las Vegas, Nevada, United States
VA Medical Center(111), Reno, Nevada, United States
Nevada Urology Associates, Reno, Nevada, United States
Carolinas Medical Centre, Charlotte,, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Urologic Specialists Of Oklahoma, Inc., Tulsa,, Oklahoma, United States
Oregon Urology Specialists, Eugene, Oregon, United States
Urological Assoc. of Lancaster, Lancaster, Pennsylvania, United States
University Of Pittsburgh, Pittsburgh, Pennsylvania, United States
Center for Urologic Care, West Reading,, Pennsylvania, United States
Center for Urologic Care, West Reading, Pennsylvania, United States
Ntouch Research Corporation, Dallas, Texas, United States
Salt Lake Research, Salt Lake City, Utah, United States
Jeffrey Frankel, M.D., Seattle,, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Tom Baker Cancer Center, Calgary,, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Cal Andreou, MD, Surrey, British Columbia, Canada
Can-Med Medical Research Inc, Victoria, British Columbia, Canada
Bruce W. Palmer Urology Inc., Kentville, Nova Scotia, Canada
The Male Health Centres, Barrie, Ontario, Canada
Burlington Professional Centre, Burlington, Ontario, Canada
Hamilton & District Urology Association, Hamilton,, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Quest Clinical Trials, Markham, Ontario, Canada
Guardian Medical Arts Bldg., North Bay, Ontario, Canada
Jack Barkin, MD, North York, Ontario, Canada
The Male Health Centres, Oakville, Ontario, Canada
Sunnybrook &Women's College Health Sciens Center, Toronto, Ontario, Canada
Hopital Notre-Dame, Montreal, Quebec, Canada
Chuq Pavillon Hotel-Dieu, Quebec, , Canada
Name: Darryl Sleep, M.D.
Affiliation: Abbott
Role: STUDY_DIRECTOR