Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT00038662
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
- prostate adenocarcinoma,
- radical prostatectomy,
- PSA between 0.4 and 5 ng/mL,
- PSADT < 1 year
- previous hormonal therapy,
- salvage therapy to the pelvis within 3 months prior to randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Carolinas Medical Centre
🇺🇸Charlotte,, North Carolina, United States
Urologic Specialists Of Oklahoma, Inc.
🇺🇸Tulsa,, Oklahoma, United States
Center for Urologic Care
🇺🇸West Reading, Pennsylvania, United States
Oregon Urology Specialists
🇺🇸Eugene, Oregon, United States
The Male Health Centres
🇨🇦Oakville, Ontario, Canada
Chuq Pavillon Hotel-Dieu
🇨🇦Quebec, Canada
Urological Assoc. of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Burlington Professional Centre
🇨🇦Burlington, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
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
Nevada Urology Associates
🇺🇸Reno, Nevada, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ntouch Research Corporation
🇺🇸Dallas, Texas, United States
Quest Clinical Trials
🇨🇦Markham, Ontario, Canada
University Of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Can-Med Medical Research Inc
🇨🇦Victoria, British Columbia, Canada
Sunnybrook &Women's College Health Sciens Center
🇨🇦Toronto, Ontario, Canada
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Guardian Medical Arts Bldg.
🇨🇦North Bay, Ontario, Canada
Urology Centers Of Alabama
🇺🇸Homewood,, Alabama, 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
Jeffrey Frankel, M.D.
🇺🇸Seattle,, Washington, United States
Hamilton & District Urology Association
🇨🇦Hamilton,, Ontario, Canada
Jack Barkin, MD
🇨🇦North York, Ontario, Canada
Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
VA Medical Center(111)
🇺🇸Reno, Nevada, United States
Cal Andreou, MD
🇨🇦Surrey, British Columbia, Canada
Bruce W. Palmer Urology Inc.
🇨🇦Kentville, Nova Scotia, Canada
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Tom Baker Cancer Center
🇨🇦Calgary,, Alberta, Canada
Sheldon Freedman MD
🇺🇸Las Vegas, Nevada, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada