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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 MedicineBronx, New York  10461
UCLA School of MedicineLos Angeles, California  900121973
Mayo ClinicRochester, Minnesota  55905
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Medical College of WisconsinMilwaukee, Wisconsin  53226
Beth Israel Medical CenterNew York, New York  10003
Madigan Army Medical CenterTacoma, Washington  98431-5048
University of Washington School of MedicineSeattle, Washington  98195
Mid Atlantic Clinical ResearchRockville, Maryland  20850
Rochester General HospitalRochester, New York  14621
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
San Diego Urology CenterLa Mesa, California  91942
Urology Treatment CenterSarasota, Florida  3429
Virginia Urology CenterRichmond, Virginia  23230
Seattle Urological AssociatesSeattle, Washington  98104-1360
University of PittsburghPittsburgh, Pennsylvania  15261
Billings Oncology AssociatesBillings, Montana  59101
Dreyer Medical ClinicAurora, Illinois  60506
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Pacific Clinical ResearchSanta Monica, California  90404
Advanced Research InstituteNew Port Richey, Florida  34652
Welborn ClinicEvansville, Indiana  47714
Center for Urologic CareWest Reading, Pennsylvania  19611
nTouch Research CorporationDallas, Texas  75230
Midwest Research Specialists, LLCMilwaukee, Wisconsin  53209
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Urology Centers Of AlabamaHomewood,, Alabama  35205
Advanced Clinical TrialsTucson, Arizona  85712
Arkansas Urologial Associates, PALittle Rock, Arkansas  72205
Robin V. Smith, MDChula Vista, California  91910
Urology Associate Of Central CaliforniaFresno,, California  93720
South Valley Medical PlazaGilroy, California  95020-3535
Hillcrest Urological Medical Group, Inc.San Diego, California  92103
Urology Associates Of San Luis ObispoSan Luis Obispo,, California  93405
Western Clinical Research, Inc.Torrance,, California  90505-4763
Urology Associate, PcDenver,, Colorado  80210
South Fl Medical ResearchAventura, Florida  33180
Clinical Physiology AssociatesFort Myers, Florida  33916
Southeastern Urological Center, P.A.Tallahassee, Florida  32308
Sandy Springs UrologyAtlanta, Georgia  30328
Winship Cancer Institute Emory UniversityAtlanta,, Georgia  30322
Atlanta Va Medical CenterDecatur, Georgia  30033
Progressive Care, S.C.Chicago, Illinois  60631
Weiss Memorial HospitalChicago,, Illinois  60640
Evanston Hospital Kellogg Cancer CenterEvanston, Illinois  60201
Urologic Associates, PcDavenport, Iowa  52807
Iowa UrologyDes Moines, Iowa  50309
Kansas University Medical CenterKansas City,, Kansas  66160-7390
Ochsner Clinic, Department of UrologyNew Orleans, Louisiana  70121
Regional UrologyShreveport, Louisiana  71106
LSUHSCShreveport, Louisiana  71130
Michigan Institute Of Urology, PcSt. Clair Shores, Michigan  48081
Lakeside Urology, PCSt. Joseph, Michigan  49085
The Medical Oncology GroupGulfport,, Mississippi  39501
St. Joseph OncologySt. Joseph, Missouri  64507
Washington UniversitySt. Louis, Missouri  63110
Nevada Urology AssociateReno, Nevada  89509
Albany Medical Center South Clinical CampusAlbany, New York  12208-3499
HemOnCare, PCBrooklyn, New York  11235
NYU Medical CenterNew York, New York  10016
Nyack HospitalNyack, New York  10960
St. Vincent's Medical Center - Staten IslandStaten Island,, New York  10310
The University Of North Carolina At Chapel HillChapel Hill, North Carolina  27599-7235
Blumenthal Cancer CenterCharlotte, North Carolina  28203
The Urology CenterGreensboro,, North Carolina  27401
Urologic Specialists Of Oklahoma, Inc.Tulsa,, Oklahoma  74104-5433
Oregon Urology SpecialistsEugene, Oregon  97401
Urologic Associates of AllentownAllentown, Pennsylvania  18103
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
Urology AssociatesNashville, Tennessee  37209
Dept of Veteran's Affairs North Texas Healthcare SystemDallas, Texas  75216
UthscsaSan Antonio, Texas  78229
Scott & White Memorial HospitalTemple,, Texas  76508
Western Urological ClinicSalt Lake City, Utah  84107
Anthony Middleton, M.D.Salt Lake City,, Utah  84102
University Of VermontBurlington,, Vermont  05403
Jeffrey Frankel, M.D.Seattle,, Washington  98166-3059
Wyoming Research FoundationCheyenne, Wyoming  82001