Know Cancer

forgot password

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
Not Enrolling
Prostate Cancer

Thank you

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:


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:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Hormone-Refractory, Prostate Cancer
  • Prostatic Neoplasms



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