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
Phase 2
19 Years
N/A
19 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
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
Inclusion Criteria:
- prostate adenocarcinoma,
- radical prostatectomy,
- PSA between 0.4 and 5 ng/mL,
- PSADT < 1 year
Exclusion Criteria:
- previous hormonal therapy,
- salvage therapy to the pelvis within 3 months prior to randomization
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Principal Investigator
Darryl Sleep, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
M01-366
NCT ID:
NCT00038662
Start Date:
May 2002
Completion Date:
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| San Diego Urology Center | La Mesa, California 91942 |
| University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
| Northwestern University | Chicago, Illinois 60611 |
| Center for Urologic Care | West Reading, Pennsylvania 19611 |
| nTouch Research Corporation | Dallas, Texas 75230 |
| Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Arkansas Urologial Associates, PA | Little Rock, Arkansas 72205 |
| Clinical Physiology Associates | Fort Myers, Florida 33916 |
| Urologic Specialists Of Oklahoma, Inc. | Tulsa,, Oklahoma 74104-5433 |
| Oregon Urology Specialists | Eugene, Oregon 97401 |
| Jeffrey Frankel, M.D. | Seattle,, Washington 98166-3059 |
| Western Clinical Research Inc | Torrance, California 90505 |
| Georgetown University Medical Center | Washington, District of Columbia 20007 |
| Southeastern Urological Center, PA | Tallahassee, Florida 32308 |
| Sheldon Freedman MD | Las Vegas, Nevada 89109 |
| VA Medical Center(111) | Reno, Nevada 89502 |
| Nevada Urology Associates | Reno, Nevada 89511 |
| Carolinas Medical Centre | Charlotte,, North Carolina 28204 |
| Urological Assoc. of Lancaster | Lancaster, Pennsylvania 17604-3200 |
| Salt Lake Research | Salt Lake City, Utah 84124 |
