Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
Completed · Phase 2
Conditions studied: Prostatic Neoplasms
In brief
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).
Key facts
- Study ID
- NCT00038662
- Run by
- Abbott
- People needed
- 200
- Starts
- 2002-05-01
- Last updated by the study team
- 2006-08-15
Who can join
Age: 19 and older. Sex: male. Healthy volunteers: not accepted.
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
Where it is running
- 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 D.C., 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
- 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
Full record on ClinicalTrials.gov
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