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A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer


Phase 3
19 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer


Inclusion Criteria:



- Have been diagnosed with prostate cancer.

- Have a rising PSA while on hormone therapy or following surgical castration.

Exclusion Criteria:

- Have evidence of distant metastatic disease on screening bone scan or CT scan.

- 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:

Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.

Outcome Time Frame:

Every 12 weeks

Principal Investigator

Gary Gordon, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M00-244

NCT ID:

NCT00036556

Start Date:

June 2001

Completion Date:

Related Keywords:

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

Name

Location

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 Nebraska Medical CenterOmaha, Nebraska  68198-3330
University of Washington School of MedicineSeattle, Washington  98195
Mid Atlantic Clinical ResearchRockville, Maryland  20850
Emory ClinicAtlanta, Georgia  30365
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Massachusetts General HospitalBoston, Massachusetts  02114-2617
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
MultiMed ResearchProvidence, Rhode Island  02906
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
Northwestern University Medical SchoolChicago, Illinois  60611-2927
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
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
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
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
South Orange County Medical Research CenterLaguna Hills, California  92653
VA Palo AltoPalo Alto, California  94304
Dattoli Cancer CenterSarasota,, Florida  34237
Peachtree Hematology/Oncology ConsultantsAtlanta, Georgia  30309
Christopher Ryan, MDChicago, Illinois  60637-1470
Welborn Clinic -EastEvansville, Indiana  47714-0981
Drs. Werner, Murdock, & Francis, Pa Urology Assoc.Greenbelt, Maryland  20770
Michigan Medical UrologyGrand Rapids, Michigan  49503
Mississippi Center For Clinical Research, LLCJackson, Mississippi  39216
UNM Medical CenterAlbuquerque, New Mexico  87131
Urology Specialists Of The CarolinasCharlotte,, North Carolina  28207
Mckay UrologyCharlotte,, North Carolina  28204
University Of Cincinnati Medical CenterCincinnati,, Ohio  45267-0589
University of TN - MemphisMemphis, Tennessee  38104
The University Of TX SW Medical Center At DallasDallas, Texas  75390-9110