A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
Phase 3
19 Years
N/A
19 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
Inclusion Criteria:
- Diagnosis of prostate cancer.
- Rising PSA while on hormonal therapy or following surgical castration.
- Documented evidence of metastatic disease.
Exclusion Criteria:
- Have received cytotoxic chemotherapy.
- Have received opioid or narcotic medications (such as codeine or morphine) or
radiation for pain caused by your prostate cancer in the last 6 months.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression
Principal Investigator
Darryl Sleep, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
M00-211
NCT ID:
NCT00036543
Start Date:
May 2001
Completion Date:
Related Keywords:
- Prostate Cancer
- Hormone-Refractory, Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Albert Einstein College of Medicine | Bronx, New York 10461 |
| UCLA School of Medicine | Los Angeles, California 900121973 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Beth Israel Medical Center | New York, New York 10003 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| University of Washington School of Medicine | Seattle, Washington 98195 |
| Mid Atlantic Clinical Research | Rockville, Maryland 20850 |
| Rochester General Hospital | Rochester, New York 14621 |
| Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
| San Diego Urology Center | La Mesa, California 91942 |
| Urology Treatment Center | Sarasota, Florida 3429 |
| Virginia Urology Center | Richmond, Virginia 23230 |
| Seattle Urological Associates | Seattle, Washington 98104-1360 |
| University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
| Billings Oncology Associates | Billings, Montana 59101 |
| Dreyer Medical Clinic | Aurora, Illinois 60506 |
| Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
| Pacific Clinical Research | Santa Monica, California 90404 |
| Advanced Research Institute | New Port Richey, Florida 34652 |
| Welborn Clinic | Evansville, Indiana 47714 |
| Center for Urologic Care | West Reading, Pennsylvania 19611 |
| nTouch Research Corporation | Dallas, Texas 75230 |
| Midwest Research Specialists, LLC | Milwaukee, Wisconsin 53209 |
| Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Advanced Clinical Trials | Tucson, Arizona 85712 |
| Arkansas Urologial Associates, PA | Little Rock, Arkansas 72205 |
| Robin V. Smith, MD | Chula Vista, California 91910 |
| Urology Associate Of Central California | Fresno,, California 93720 |
| South Valley Medical Plaza | Gilroy, California 95020-3535 |
| Hillcrest Urological Medical Group, Inc. | San Diego, California 92103 |
| Urology Associates Of San Luis Obispo | San Luis Obispo,, California 93405 |
| Western Clinical Research, Inc. | Torrance,, California 90505-4763 |
| Urology Associate, Pc | Denver,, Colorado 80210 |
| South Fl Medical Research | Aventura, Florida 33180 |
| Clinical Physiology Associates | Fort Myers, Florida 33916 |
| Southeastern Urological Center, P.A. | Tallahassee, Florida 32308 |
| Sandy Springs Urology | Atlanta, Georgia 30328 |
| Winship Cancer Institute Emory University | Atlanta,, Georgia 30322 |
| Atlanta Va Medical Center | Decatur, Georgia 30033 |
| Progressive Care, S.C. | Chicago, Illinois 60631 |
| Weiss Memorial Hospital | Chicago,, Illinois 60640 |
| Evanston Hospital Kellogg Cancer Center | Evanston, Illinois 60201 |
| Urologic Associates, Pc | Davenport, Iowa 52807 |
| Iowa Urology | Des Moines, Iowa 50309 |
| Kansas University Medical Center | Kansas City,, Kansas 66160-7390 |
| Ochsner Clinic, Department of Urology | New Orleans, Louisiana 70121 |
| Regional Urology | Shreveport, Louisiana 71106 |
| LSUHSC | Shreveport, Louisiana 71130 |
| Michigan Institute Of Urology, Pc | St. Clair Shores, Michigan 48081 |
| Lakeside Urology, PC | St. Joseph, Michigan 49085 |
| The Medical Oncology Group | Gulfport,, Mississippi 39501 |
| St. Joseph Oncology | St. Joseph, Missouri 64507 |
| Washington University | St. Louis, Missouri 63110 |
| Nevada Urology Associate | Reno, Nevada 89509 |
| Albany Medical Center South Clinical Campus | Albany, New York 12208-3499 |
| HemOnCare, PC | Brooklyn, New York 11235 |
| NYU Medical Center | New York, New York 10016 |
| Nyack Hospital | Nyack, New York 10960 |
| St. Vincent's Medical Center - Staten Island | Staten Island,, New York 10310 |
| The University Of North Carolina At Chapel Hill | Chapel Hill, North Carolina 27599-7235 |
| Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| The Urology Center | Greensboro,, North Carolina 27401 |
| Urologic Specialists Of Oklahoma, Inc. | Tulsa,, Oklahoma 74104-5433 |
| Oregon Urology Specialists | Eugene, Oregon 97401 |
| Urologic Associates of Allentown | Allentown, Pennsylvania 18103 |
| Urological Associates Of Lancaster | Lancaster, Pennsylvania 17604-3200 |
| Urology Associates | Nashville, Tennessee 37209 |
| Dept of Veteran's Affairs North Texas Healthcare System | Dallas, Texas 75216 |
| Uthscsa | San Antonio, Texas 78229 |
| Scott & White Memorial Hospital | Temple,, Texas 76508 |
| Western Urological Clinic | Salt Lake City, Utah 84107 |
| Anthony Middleton, M.D. | Salt Lake City,, Utah 84102 |
| University Of Vermont | Burlington,, Vermont 05403 |
| Jeffrey Frankel, M.D. | Seattle,, Washington 98166-3059 |
| Wyoming Research Foundation | Cheyenne, Wyoming 82001 |
