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)
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
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