Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,589

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Preneoplastic ConditionsProstatic Intraepithelial Neoplasia
Interventions
DRUG

Toremifene 20 mg

The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).

DRUG

Placebo

The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Trial Locations (138)

10016

NYU Urology Associates, New York

University Urology Associates, New York

10304

Staten Island Urological Research, Staten Island

11003

Metropolitan Urologic Services, P.C., Elmont

11030

Urology Associates, PC, Manhasset

11042

Lake Success Urological Associates, Lake Success

11530

AccuMed Research Associates, Garden City

Urological Surgeons of Long Island, Garden City

12208

The Urological Institute of Northeastern Research Department, Albany

13421

CNY Urology, Oneida

15146

The Urology Institute, Monroeville

15212

Triangle Urological Group, Pittsburgh

15232

University of Pittsburgh, Department of Urology, Pittsburgh

16801

State College Urologic Associates, Inc., State College

17604

Urological Associates of Lancaster, Ltd., Lancaster

18103

Urologic Associates of Allentown, Allentown

19004

Urologic Surgery, P.C., Bala-Cynwyd

19104

University of Pennsylvania, Philadelphia

20770

Drs. Werner, Murdock, & Francis PA, Urology Associates, Greenbelt

21201

Maryland Prostate Center: University of Maryland Medical Center, Baltimore

21204

Chesapeake Urology Research Assoc., Towson

21401

Anne Arundel Urology, Annapolis

21742

Urology Center, PA, Hagerstown

23235

Med Atlantic, Inc (Virginia Urology), Richmond

23502

Devine-Tidewater Urology, Norfolk

27203

Asheboro Urology Clinic, Asheboro

27607

Wake Urology Associates, Raleigh

28050

Mid Atlantic Clinical Research, Rockville

28204

McKay Urology, Charlotte

29201

Columbia Urological Associates, Columbia

29572

Carolina Urologic Research Center, Myrtle Beach

30060

Urology Enterprises, Marietta

30076

North Fulton Urology, Roswell

30308

Midtown Urology, Atlanta

30342

Georgia Urology, Atlanta

31405

St. Joseph's, Candler Health System, Savannah

32114

Atlantic Urological Associates, Daytona Beach

32405

Panama City Urological Center, Panama City

32803

Winter Park Urology Associates, Orlando

33028

Demaur Clinical Research Center, Pembroke Pines

33180

South Florida Medical Research, Aventura

33782

DMI Research, Pinellas Park

Urology Consultants, Pinellas Park

33907

Southwest Florida Urologic Associates, Fort Myers

34237

Florida Urology Specialists, Sarasota

34471

UroSearch, Ocala

34474

Central Florida Urology Group/ UroSearch, Ocala

Florida Foundation for Healthcare Research, Ocala

34652

Advanced Research Institute, New Port Richey

35801

Medical Affiliated Research Ctr., Huntsville

36608

Coastal Clinical Research, Mobile

37209

Urology Associates, Nashville

37920

Volunteer Research Group, Knoxville

38119

Southeast Urology Network, Memphis

38138

Urology Center of the South, Germantown

38163

University of Tennessee, Dept. of Urology, Memphis

43214

Capital Urology, Columbus

Columbus Urology, Inc., Columbus

44035

Urology of Northern Ohio, Elyria

44130

Southwest Urology, Middleburg Heights

44304

Summa Health System, Cancer Research Office, Akron

45212

Tri-State Urologic Services/PSC, Inc. d/b/a The Urology Group, Cincinnati

46254

Urology of Indiana, LLC, Indianapolis

47130

Metropolitan Urology, PSC, Jeffersonville

48081

Mich. Inst. of Urology, Saint Clair Shores

49546

Michigan Medical, PC Urology, Grand Rapids

56377

Adult & Pediatric Urology, Sartell

61614

Specialty Care Research, Peoria

63017

St. Louis Urological Surgeons, Chesterfield

63031

Metropolitan Urological Specialists, Florissant

63110

Washington University Urologic Research Ctr., St Louis

64055

Midwest Urology Center, Independence

66211

Kansas City Urology Care, P.C., Overland Park

68516

Urology PC, Lincoln

71106

Regional Urology, LLC, Shreveport

72211

Arkansas Urology, Little Rock

73008

Parkhurst Research Organization, Bethany

74104

Urologic Specialists of Oklahoma Research Department, Tulsa

75234

Research Across America, Dallas

78229

Urology San Antonio Research, PA, San Antonio

78756

Professional Quality Research, Austin

80012

Urology Research Options, Aurora

80210

Urology Associates, P.C., Denver

80211

The Urology Center of Colorado, Denver

84102

Advanced Clinical Research, Salt Lake City

84107

Salt Lake Research, Salt Lake City

85032

Hope Research Inst., Phoenix

87109

Urology Group of New Mexico, Albuquerque

89109

Sheldon Freeman, Las Vegas

89502

Urologic Surgeons, Ltd., Reno

90505

Western Clinical Research, Inc., Torrance

92404

San Bernardino Urological Associates Medical Group, San Bernardino

97477

Oregon Urology Specialists, Springfield

98104

Seattle Urological Associates, Seattle

98405

Urologic Northwest Surgeons, Tacoma

98431

Urology Services Madigan Army Medical Center, Tacoma

99204

Deaconess Medical Center, Spokane

06106

Connecticut Surgical Group, Hartford

06611

Urological Associates of Bridgeport, Trumbull

06708

Connecticut Clinical Research, Waterbury

02115

Brigham & Women's Hospital, Division of Urological Surgery, Boston

02135

Boston Clinical Trials, Brighton

08724

Coastal Urology Associates, Brick

08837

Central Jersey Clinical Research, Edison

08690

Hamilton Urology PA, Hamilton

08053

Delaware Valley Urology, Marlton

08054

Delaware Valley Urology, Mount Laurel

02904

University Urological Research Institute, Providence

Unknown

Centro Urologico Buenos Aires, Buenos Aires

Hospital Italiano de Buenos Aires, Buenos Aires

Hospital Pirovano, Buenos Aires

Policlinico Bancario de Buenos Aires, Buenos Aires

Sanatorio Municipal, Buenos Aires

Servicio de Urologia, Buenos Aires

Prostate Cancer Inst., Calgary

T5H4B9

Alberta Urology Inst.. Research Center, Edmonton

V1H 2H4

Southern Interior Medical Research Inc., Kelowna

V8V3N1

Dr. G. Steinhoff Clinical Research, Victoria

E3B5B8

Allan B. Patrick, M.D. Professional corporation, Fredericton

B3H 1V7

Queen Elizabeth Health Sciences Centre, Halifax

L4M 7G1

Male/Female Health and Research Centre, Barrie

L7N 3V2

Burlington Urology, Burlington

K7L 3J7

Centre for Advanced Urological Research, Kingston

N2N 2B9

Urology Assoc./Urologic Medical Research, Kitchener

N6A 5W9

London Health Sciences Centre, London

L3X 1W1

Mor Urology, Newmarket

L6H 3P1

The Fe/Male Health Centres, Oakville

L1H 7K4

Urotec, Oshawa

M1P 2T7

The Health Institute for Men, Toronto

M3B 3S6

Stanley Flax Medical Professional Corp., Toronto

M5G 2M9

Univ. Health Network, Princess Margaret Hospital Prostate Centre, Toronto

M6A 3B5

The Male Health Centre, Toronto

M2K 2W1

Roger Buckley, MD, Willowdale

J4V 2H3

Urology South Shore Research, Greenfield Park

H2X 1N8

Les Urologues Associes du CHUM, Montreal

H3S 1Z1

McGill Urology Associates, Montreal

H9R 4S3

Ultra-Med, Inc., Pointe-Claire

G9A 3V7

G.R.U.M., Trois-Rivières

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GTx

INDUSTRY

NCT00106691 - Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia) | Biotech Hunter | Biotech Hunter