Spots Global Cancer Trial Database for Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
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Trial Identification
Brief Title: Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
Study ID: NCT00106691
Study Description
Brief Summary: The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
Detailed Description: The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Medical Affiliated Research Ctr., Huntsville, Alabama, United States
Coastal Clinical Research, Mobile, Alabama, United States
Hope Research Inst., Phoenix, Arizona, United States
Arkansas Urology, Little Rock, Arkansas, United States
San Bernardino Urological Associates Medical Group, San Bernardino, California, United States
Western Clinical Research, Inc., Torrance, California, United States
Urology Research Options, Aurora, Colorado, United States
Urology Associates, P.C., Denver, Colorado, United States
The Urology Center of Colorado, Denver, Colorado, United States
Connecticut Surgical Group, Hartford, Connecticut, United States
Urological Associates of Bridgeport, Trumbull, Connecticut, United States
Connecticut Clinical Research, Waterbury, Connecticut, United States
South Florida Medical Research, Aventura, Florida, United States
Atlantic Urological Associates, Daytona Beach, Florida, United States
Southwest Florida Urologic Associates, Fort Myers, Florida, United States
Advanced Research Institute, New Port Richey, Florida, United States
UroSearch, Ocala, Florida, United States
Central Florida Urology Group/ UroSearch, Ocala, Florida, United States
Florida Foundation for Healthcare Research, Ocala, Florida, United States
Winter Park Urology Associates, Orlando, Florida, United States
Panama City Urological Center, Panama City, Florida, United States
Demaur Clinical Research Center, Pembroke Pines, Florida, United States
DMI Research, Pinellas Park, Florida, United States
Urology Consultants, Pinellas Park, Florida, United States
Florida Urology Specialists, Sarasota, Florida, United States
Midtown Urology, Atlanta, Georgia, United States
Georgia Urology, Atlanta, Georgia, United States
Urology Enterprises, Marietta, Georgia, United States
North Fulton Urology, Roswell, Georgia, United States
St. Joseph's, Candler Health System, Savannah, Georgia, United States
Specialty Care Research, Peoria, Illinois, United States
Urology of Indiana, LLC, Indianapolis, Indiana, United States
Metropolitan Urology, PSC, Jeffersonville, Indiana, United States
Kansas City Urology Care, P.C., Overland Park, Kansas, United States
Regional Urology, LLC, Shreveport, Louisiana, United States
Anne Arundel Urology, Annapolis, Maryland, United States
Maryland Prostate Center: University of Maryland Medical Center, Baltimore, Maryland, United States
Drs. Werner, Murdock, & Francis PA, Urology Associates, Greenbelt, Maryland, United States
Urology Center, PA, Hagerstown, Maryland, United States
Mid Atlantic Clinical Research, Rockville, Maryland, United States
Chesapeake Urology Research Assoc., Towson, Maryland, United States
Brigham & Women's Hospital, Division of Urological Surgery, Boston, Massachusetts, United States
Boston Clinical Trials, Brighton, Massachusetts, United States
Michigan Medical, PC Urology, Grand Rapids, Michigan, United States
Mich. Inst. of Urology, Saint Clair Shores, Michigan, United States
Adult & Pediatric Urology, Sartell, Minnesota, United States
St. Louis Urological Surgeons, Chesterfield, Missouri, United States
Metropolitan Urological Specialists, Florissant, Missouri, United States
Midwest Urology Center, Independence, Missouri, United States
Washington University Urologic Research Ctr., Saint Louis, Missouri, United States
Urology PC, Lincoln, Nebraska, United States
Sheldon Freeman, Las Vegas, Nevada, United States
Urologic Surgeons, Ltd., Reno, Nevada, United States
Coastal Urology Associates, Brick, New Jersey, United States
Central Jersey Clinical Research, Edison, New Jersey, United States
Hamilton Urology PA, Hamilton, New Jersey, United States
Delaware Valley Urology, Marlton, New Jersey, United States
Delaware Valley Urology, Mount Laurel, New Jersey, United States
Urology Group of New Mexico, Albuquerque, New Mexico, United States
The Urological Institute of Northeastern Research Department, Albany, New York, United States
Metropolitan Urologic Services, P.C., Elmont, New York, United States
AccuMed Research Associates, Garden City, New York, United States
Urological Surgeons of Long Island, Garden City, New York, United States
Lake Success Urological Associates, Lake Success, New York, United States
Urology Associates, PC, Manhasset, New York, United States
NYU Urology Associates, New York, New York, United States
University Urology Associates, New York, New York, United States
CNY Urology, Oneida, New York, United States
Staten Island Urological Research, Staten Island, New York, United States
Asheboro Urology Clinic, Asheboro, North Carolina, United States
McKay Urology, Charlotte, North Carolina, United States
Wake Urology Associates, Raleigh, North Carolina, United States
Summa Health System, Cancer Research Office, Akron, Ohio, United States
Tri-State Urologic Services/PSC, Inc. d/b/a The Urology Group, Cincinnati, Ohio, United States
Capital Urology, Columbus, Ohio, United States
Columbus Urology, Inc., Columbus, Ohio, United States
Urology of Northern Ohio, Elyria, Ohio, United States
Southwest Urology, Middleburg Heights, Ohio, United States
Parkhurst Research Organization, Bethany, Oklahoma, United States
Urologic Specialists of Oklahoma Research Department, Tulsa, Oklahoma, United States
Oregon Urology Specialists, Springfield, Oregon, United States
Urologic Associates of Allentown, Allentown, Pennsylvania, United States
Urologic Surgery, P.C., Bala-Cynwyd, Pennsylvania, United States
Urological Associates of Lancaster, Ltd., Lancaster, Pennsylvania, United States
The Urology Institute, Monroeville, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Triangle Urological Group, Pittsburgh, Pennsylvania, United States
University of Pittsburgh, Department of Urology, Pittsburgh, Pennsylvania, United States
State College Urologic Associates, Inc., State College, Pennsylvania, United States
University Urological Research Institute, Providence, Rhode Island, United States
Columbia Urological Associates, Columbia, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Center of the South, Germantown, Tennessee, United States
Volunteer Research Group, Knoxville, Tennessee, United States
Southeast Urology Network, Memphis, Tennessee, United States
University of Tennessee, Dept. of Urology, Memphis, Tennessee, United States
Urology Associates, Nashville, Tennessee, United States
Professional Quality Research, Austin, Texas, United States
Research Across America, Dallas, Texas, United States
Urology San Antonio Research, PA, San Antonio, Texas, United States
Advanced Clinical Research, Salt Lake City, Utah, United States
Salt Lake Research, Salt Lake City, Utah, United States
Devine-Tidewater Urology, Norfolk, Virginia, United States
Med Atlantic, Inc (Virginia Urology), Richmond, Virginia, United States
Seattle Urological Associates, Seattle, Washington, United States
Deaconess Medical Center, Spokane, Washington, United States
Urologic Northwest Surgeons, Tacoma, Washington, United States
Urology Services Madigan Army Medical Center, Tacoma, Washington, United States
Centro Urologico Buenos Aires, Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires, Buenos Aires, , Argentina
Hospital Pirovano, Buenos Aires, , Argentina
Policlinico Bancario de Buenos Aires, Buenos Aires, , Argentina
Sanatorio Municipal, Buenos Aires, , Argentina
Servicio de Urologia, Buenos Aires, , Argentina
Prostate Cancer Inst., Calgary, Alberta, Canada
Alberta Urology Inst.. Research Center, Edmonton, Alberta, Canada
Southern Interior Medical Research Inc., Kelowna, British Columbia, Canada
Dr. G. Steinhoff Clinical Research, Victoria, British Columbia, Canada
Allan B. Patrick, M.D. Professional corporation, Fredericton, New Brunswick, Canada
Queen Elizabeth Health Sciences Centre, Halifax, Nova Scotia, Canada
Male/Female Health and Research Centre, Barrie, Ontario, Canada
Burlington Urology, Burlington, Ontario, Canada
Centre for Advanced Urological Research, Kingston, Ontario, Canada
Urology Assoc./Urologic Medical Research, Kitchener, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Mor Urology, Newmarket, Ontario, Canada
The Fe/Male Health Centres, Oakville, Ontario, Canada
Urotec, Oshawa, Ontario, Canada
The Health Institute for Men, Toronto, Ontario, Canada
Stanley Flax Medical Professional Corp., Toronto, Ontario, Canada
Univ. Health Network, Princess Margaret Hospital Prostate Centre, Toronto, Ontario, Canada
The Male Health Centre, Toronto, Ontario, Canada
Roger Buckley, MD, Willowdale, Ontario, Canada
Urology South Shore Research, Greenfield Park, Quebec, Canada
Les Urologues Associes du CHUM, Montreal, Quebec, Canada
McGill Urology Associates, Montreal, Quebec, Canada
Ultra-Med, Inc., Pointe Claire, Quebec, Canada
G.R.U.M., Trois-Rivieres, Quebec, Canada
Contact Details
Name: Samir Taneja, MD
Affiliation: NYU Langone Medical Center
Role: PRINCIPAL_INVESTIGATOR
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