Animal Research |
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Clinical Trial: "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
This study is no longer recruiting patients.
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Purpose
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Prostate Cancer | Drug: Oral investigational prostate cancer risk reduction drug | Phase III |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: Male
Criteria
Inclusion criteria:
- Informed consent to participate in study.
- Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
- Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
- Ability and will to participate in study for 4 years.
Exclusion criteria:
- More than one previous negative prostate biopsy.
- History of prostate cancer.
- Previous prostate surgery.
- Inability to urinate requiring the need of a catheter during the previous 2 years.
- Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
- Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
- Any unstable serious medical condition.
- Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.
Location Information
Alabama
Columbiana, Alabama, 35051, United States
Birmingham, Alabama, 35205, United States
Homewood, Alabama, 35209, United States
Birmingham, Alabama, 35209, United States
Huntsville, Alabama, 35801, United States
Mobile, Alabama, 36608, United States
Alaska
Anchorage, Alaska, 99508, United States
Arizona
Phoenix, Arizona, 85023, United States
Phoenix, Arizona, 85032, United States
Scottsdale, Arizona, 85285, United States
Tucson, Arizona, 85712, United States
Tucson, Arizona, 85712, United States
Arkansas
Little Rock, Arkansas, 72205, United States
Little Rock, Arkansas, 72211, United States
California
Los Angeles, California, 90024, United States
Los Angeles, California, 90033, United States
Los Angeles, California, 90045, United States
Los Angeles, California, 90048, United States
Los Angeles, California, 90048, United States
Los Angeles, California, 90059, United States
Los Angeles, California, 90059, United States
Los Angeles, California, 90073, United States
Culver City, California, 90232, United States
Santa Monica, California, 90404, United States
Torrance, California, 90505, United States
Pico Rivera, California, 90660, United States
Long Beach, California, 90806, United States
Encino, California, 91316, United States
Tarzana, California, 91356, United States
Upland, California, 91786, United States
La Mesa, California, 91942, United States
La Mesa, California, 91942, United States
Poway, California, 92064, United States
San Diego, California, 92101, United States
San Diego, California, 92103, United States
San Diego, California, 92120, United States
San Diego, California, 92120, United States
San Diego, California, 92128, United States
San Bernardino, California, 92404, United States
Temecula, California, 92591, United States
Irvine, California, 92618, United States
Laguna Woods, California, 92653, United States
Newport Beach, California, 92660, United States
Fountain Valley, California, 92708, United States
Anaheim, California, 92801, United States
Orange, California, 92869, United States
Fresno, California, 93720, United States
Salinas, California, 93901, United States
Atherton, California, 94044, United States
San Francisco, California, 94108, United States
San Francisco, California, 94121, United States
Stanford, California, 94305, United States
Stanford, California, 94305, United States
Walnut Creek, California, 94598, United States
Mather, California, 95655, United States
Sacramento, California, 95816, United States
Colorado
Aurora, Colorado, 80010, United States
Aurora, Colorado, 80012, United States
Wheat Ridge, Colorado, 80033, United States
Denver, Colorado, 80210, United States
Denver, Colorado, 80220, United States
Longmont, Colorado, 80501, United States
Connecticut
New Britain, Connecticut, 06052, United States
Hartford, Connecticut, 06106, United States
New Haven, Connecticut, 06511, United States
Trumbull, Connecticut, 06611, United States
Waterbury, Connecticut, 06708, United States
District of Columbia
Washington, District of Columbia, 20307, United States
Florida
Orange Park, Florida, 32073, United States
Port Orange, Florida, 32127, United States
Jacksonville, Florida, 32216, United States
Jacksonville, Florida, 32224, United States
Tallahassee, Florida, 32308, United States
Panama City, Florida, 32405, United States
Longwood, Florida, 32750, United States
Orlando, Florida, 32803, United States
Melbourne, Florida, 32901, United States
Melbourne, Florida, 32904, United States
Margate, Florida, 33063, United States
Pinecrest, Florida, 33156, United States
Aventura, Florida, 33180, United States
Plantation, Florida, 33317, United States
Tamarack, Florida, 33321, United States
West Palm Beach, Florida, 33409, United States
Lake Worth, Florida, 33461, United States
Delray Beach, Florida, 33484, United States
St. Petersburg, Florida, 33703, United States
Clearwater, Florida, 33756, United States
Clearwater, Florida, 33761, United States
Clearwater, Florida, 33761, United States
Fort Myers, Florida, 33916, United States
Sarasota, Florida, 34237, United States
Ocala, Florida, 34470, United States
Ocala, Florida, 34474, United States
New Port Richey, Florida, 34652, United States
Okeechobee, Florida, 34972, United States
Stuart, Florida, 34996, United States
Georgia
Marietta, Georgia, 30060, United States
Roswell, Georgia, 30076, United States
Woodstock, Georgia, 30189, United States
Fayetteville, Georgia, 30214, United States
Atlanta, Georgia, 30308, United States
Atlanta, Georgia, 30309, United States
Atlanta, Georgia, 30342, United States
Augusta, Georgia, 30912, United States
Hawaii
Honolulu, Hawaii, 96813, United States
Idaho
Coeur D Alene, Idaho, 83814, United States
Illinois
Maywood, Illinois, 60153, United States
Melrose Park, Illinois, 60160, United States
Chicago, Illinois, 60612, United States
Chicago, Illinois, 60612, United States
Chicago, Illinois, 60616, United States
Chicago, Illinois, 60637, United States
Chicago, Illinois, 60640, United States
Niles, Illinois, 60714, United States
Kankakee, Illinois, 60901, United States
Galesburg, Illinois, 61401, United States
Springfield, Illinois, 62794, United States
Indiana
Indianapolis, Indiana, 46202, United States
Indianapolis, Indiana, 46254, United States
Fort Wayne, Indiana, 46825, United States
Jeffersonville, Indiana, 47130, United States
Kansas
Kansas City, Kansas, 66160, United States
Overland Park, Kansas, 66215, United States
Witchita, Kansas, 67208, United States
Kentucky
Lexington, Kentucky, 40509, United States
Louisiana
Metairie, Louisiana, 70001, United States
Gretna, Louisiana, 70056, United States
New Orleans, Louisiana, 70112, United States
New Orleans, Louisiana, 70115, United States
New Orleans, Louisiana, 70115, United States
New Orleans, Louisiana, 70119, United States
New Orleans, Louisiana, 70121, United States
Houma, Louisiana, 70360, United States
Covington, Louisiana, 70433, United States
Lafayette, Louisiana, 70503, United States
Shreveport, Louisiana, 71106, United States
Ruston, Louisiana, 71270, United States
Maryland
Greenbelt, Maryland, 20770, United States
Rockville, Maryland, 20850, United States
Glen Burnie, Maryland, 21061, United States
Owings Mills, Maryland, 21117, United States
Baltimore, Maryland, 21201, United States
Towson, Maryland, 21204, United States
Annapolis, Maryland, 21401, United States
Massachusetts
Springfield, Massachusetts, 01107, United States
Worcester, Massachusetts, 01605, United States
Milford, Massachusetts, 01757, United States
Salisbury, Massachusetts, 01952, United States
Salisbury, Massachusetts, 01952, United States
Boston, Massachusetts, 02115, United States
Stoneham, Massachusetts, 02180, United States
Braintree, Massachusetts, 02184, United States
Waltham, Massachusetts, 02453, United States
Newton, Massachusetts, 02462, United States
Watertown, Massachusetts, 02472, United States
West Yarmouth, Massachusetts, 02673, United States
Michigan
Royal Oak, Michigan, 48073, United States
Ann Arbor, Michigan, 48106, United States
Detroit, Michigan, 48202, United States
St. Joseph, Michigan, 49085, United States
Minnesota
Chaska, Minnesota, 55318, United States
Minneapolis, Minnesota, 55407, United States
St. Louis Park, Minnesota, 55426, United States
Rochester, Minnesota, 55905, United States
St. Cloud, Minnesota, 56303, United States
Mississippi
Jackson, Mississippi, 39202, United States
Hattiesburg, Mississippi, 39401, United States
Missouri
St. Louis, Missouri, 63110, United States
St. Louis, Missouri, 63136, United States
St. Louis, Missouri, 63141, United States
St. Louis, Missouri, 63141, United States
Kansas City, Missouri, 64131, United States
Springfield, Missouri, 65807, United States
Montana
Billings, Montana, 59102, United States
Nebraska
Omaha, Nebraska, 68114, United States
Omaha, Nebraska, 68131, United States
Nevada
Henderson, Nevada, 89014, United States
Las Vegas, Nevada, 89106, United States
Las Vegas, Nevada, 89109, United States
Reno, Nevada, 89511, United States
New Hampshire
Lebanon, New Hampshire, 03756, United States
New Jersey
West Orange, New Jersey, 07052, United States
Hackensack, New Jersey, 07601, United States
Morristown, New Jersey, 07960, United States
Voorhees, New Jersey, 08043, United States
Marlton, New Jersey, 08053, United States
Stratford, New Jersey, 08084, United States
Somers Point, New Jersey, 08244, United States
Lawrenceville, New Jersey, 08648, United States
Edison, New Jersey, 08837, United States
Hillsborough, New Jersey, 08844, United States
New York
New York, New York, 10016, United States
New York, New York, 10016, United States
New York, New York, 10021, United States
New York, New York, 10032, United States
New York, New York, 10032, United States
Staten Island, New York, 10304, United States
Bronx, New York, 10467, United States
Elmont, New York, 11003, United States
Great Neck, New York, 11021, United States
Great Neck, New York, 11021, United States
Brooklyn, New York, 11234, United States
Mineola, New York, 11501, United States
Garden City, New York, 11530, United States
Garden City, New York, 11530, United States
Albany, New York, 12208, United States
Poughkeepsie, New York, 12601, United States
East Syracuse, New York, 13057, United States
Syracuse, New York, 13210, United States
Syracuse, New York, 13210, United States
Endwell, New York, 13760, United States
Binghamton, New York, 13901, United States
Orchard Park, New York, 14127, United States
Rochester, New York, 14642, United States
North Carolina
Winston Salem, North Carolina, 27103, United States
Cary, North Carolina, 27511, United States
Cary, North Carolina, 27511, United States
Chapel Hill, North Carolina, 27514, United States
Raleigh, North Carolina, 27607, United States
Raleigh, North Carolina, 27612, United States
Durham, North Carolina, 27710, United States
Greenville, North Carolina, 27834, United States
Concord, North Carolina, 28025, United States
Charlotte, North Carolina, 28204, United States
Charlotte, North Carolina, 28211, United States
Charlotte, North Carolina, 28262, United States
North Dakota
Bismarck, North Dakota, 58501, United States
Ohio
Columbus, Ohio, 43214, United States
Columbus, Ohio, 43214, United States
Columbus, Ohio, 43214, United States
Columbus, Ohio, 43235, United States
Marion, Ohio, 43302, United States
Toledo, Ohio, 43614, United States
Zanesville, Ohio, 43701, United States
Sheffield, Ohio, 44035, United States
Cleveland, Ohio, 44195, United States
Cincinnati, Ohio, 45212, United States
Cincinnati, Ohio, 45267, United States
Kettering, Ohio, 45429, United States
Oklahoma
Oklahoma City, Oklahoma, 73112, United States
Tulsa, Oklahoma, 74131, United States
Ponca City, Oklahoma, 74601, United States
Oregon
Oregon City, Oregon, 97045, United States
Portland, Oregon, 97205, United States
Portland, Oregon, 97210, United States
Eugene, Oregon, 97401, United States
Pennsylvania
Bryn Mawr, Pennsylvania, 10910, United States
Monroeville, Pennsylvania, 15146, United States
Pittsburgh, Pennsylvania, 15212, United States
Pittsburgh, Pennsylvania, 15232, United States
State College, Pennsylvania, 16801, United States
Camp Hill, Pennsylvania, 17011, United States
Hershey, Pennsylvania, 17033, United States
Harrisburg, Pennsylvania, 17110, United States
Lancaster, Pennsylvania, 17601, United States
Lancaster, Pennsylvania, 17604, United States
Newtown, Pennsylvania, 18940, United States
Sellersville, Pennsylvania, 18960, United States
Bala Cynwyd, Pennsylvania, 19004, United States
Bryn Mawr, Pennsylvania, 19010, United States
Philadelphia, Pennsylvania, 19107, United States
Philadelphia, Pennsylvania, 19115, United States
Philadelphia, Pennsylvania, 19124, United States
Philadelphia, Pennsylvania, 19141, United States
Philadelphia, Pennsylvania, 19144, United States
Rhode Island
West Warwick, Rhode Island, 02893, United States
Providence, Rhode Island, 02904, United States
Cranston, Rhode Island, 02920, United States
South Carolina
Charleston, South Carolina, 29425, United States
Myrtle Beach, South Carolina, 29572, United States
Greer, South Carolina, 29650, United States
Greer, South Carolina, 29651, United States
Simpsonville, South Carolina, 29681, United States
South Dakota
Ft. Pierre, South Dakota, 57501, United States
Tennessee
Nashville, Tennessee, 37209, United States
Nashville, Tennessee, 37232, United States
Knoxville, Tennessee, 37920, United States
Memphis, Tennessee, 38119, United States
Milan, Tennessee, 38358, United States
Texas
Dallas, Texas, 75216, United States
Dallas, Texas, 75230, United States
Dallas, Texas, 75231, United States
Dallas, Texas, 75234, United States
Dallas, Texas, 75390, United States
Texarkana, Texas, 75501, United States
Arlington, Texas, 76017, United States
Fort Worth, Texas, 76104, United States
Fort Worth, Texas, 76107, United States
Houston, Texas, 77024, United States
Houston, Texas, 77030, United States
Houston, Texas, 77033, United States
Galveston, Texas, 77555, United States
San Antonio, Texas, 78229, United States
San Antonio, Texas, 78229, United States
San Antonio, Texas, 78229, United States
Austin, Texas, 78756, United States
Amarillo, Texas, 79106, United States
Utah
Salt Lake City, Utah, 84124, United States
Vermont
South Burlington, Vermont, 05403, United States
Virginia
Fairfax, Virginia, 22031, United States
Alexandria, Virginia, 22302, United States
Harrisonburg, Virginia, 22801, United States
Charlottesville, Virginia, 22911, United States
Richmond, Virginia, 23235, United States
Richmond, Virginia, 23249, United States
Richmond, Virginia, 23298, United States
Norfolk, Virginia, 23454, United States
Virginia Beach, Virginia, 23455, United States
Norfolk, Virginia, 23502, United States
Norfolk, Virginia, 23502, United States
Salem, Virginia, 24153, United States
Washington
Seattle, Washington, 98101, United States
Seattle, Washington, 98108, United States
Seattle, Washington, 98122, United States
Seattle, Washington, 98133, United States
Seattle, Washington, 98166, United States
Seattle, Washington, 98195, United States
Graham, Washington, 98338, United States
Tacoma, Washington, 98405, United States
Tacoma, Washington, 98431, United States
Lakewood, Washington, 98499, United States
Spokane, Washington, 99204, United States
Spokane, Washington, 99207, United States
West Virginia
Wheeling, West Virginia, 26003, United States
Wisconsin
Milwaukee, Wisconsin, 53209, United States
Milwaukee, Wisconsin, 53209, United States
Milwaukee, Wisconsin, 53215, United States
Madison, Wisconsin, 53715, United States
Wyoming
Cheyenne, Wyoming, 82001, United States
Australia, New South Wales
Darlinghurst, New South Wales, 2010, Australia
Australia, South Australia
Adelaide, South Australia, 5000, Australia
Australia, Victoria
Randwick, Victoria, 2031, Australia
Parkville, Victoria, 3050, Australia
Mentone, Victoria, 3194, Australia
Austria
Wien, A 1090, Austria
Wien, A 1180, Austria
Innsbruck, A 6020, Austria
Wien, A-1090, Austria
Belgium
Brussels, 1070, Belgium
Brussels, 1200, Belgium
Antwerpen, 2020, Belgium
Leuven, 3000, Belgium
Canada, Alberta
Calgary, Alberta, T2V 4R6, Canada
Red Deer, Alberta, T4N 4E7, Canada
Edmonton, Alberta, T6G 2C8, Canada
Canada, British Columbia
Kelowna, British Columbia, V1Y 2H4, Canada
Surrey, British Columbia, V3V 1N1, Canada
Vancouver, British Columbia, V5Z 3J5, Canada
Victoria, British Columbia, V8T 5G1, Canada
Victoria, British Columbia, V8V 3N1, Canada
Canada, New Brunswick
Miramichi, New Brunswick, E1V 1N9, Canada
Saint John, New Brunswick, E2L 3J8, Canada
Fredericton, New Brunswick, E3B 5B8, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, B3H 1Y6, Canada
Kentville, Nova Scotia, B4N 4K9, Canada
Canada, Ontario
Kingston, Ontario, K7L 2V7, Canada
Niagara Falls, Ontario, L2E 7H1, Canada
Orillia, Ontario, L3V 7V1, Canada
Newmarket, Ontario, L3X 1W1, Canada
Richmond Hill, Ontario, L4C 1T6, Canada
Barrie, Ontario, L4M 4S5, Canada
Markham, Ontario, L6B 1A1, Canada
Oakville, Ontario, L6H 3P1, Canada
Brampton, Ontario, L6T 3J1, Canada
Burlington, Ontario, L7N 3V2, Canada
Burlington, Ontario, L7S 1V2, Canada
Toronto, Ontario, M1S 4V5, Canada
Toronto, Ontario, M3H 5S4, Canada
Study Site - North Toronto, Toronto, Ontario, M4N 3M5, Canada
Study Site - Central Toronto, Toronto, Ontario, M5G 2M9, Canada
Study Site - North Toronto, Toronto, Ontario, M6A 3B5, Canada
Kitchener, Ontario, N2M 5N4, Canada
North Bay, Ontario, P1B 4Z2, Canada
Canada, Quebec
Quebec City, Quebec, G1S 2L6, Canada
Chicoutimi, Quebec, G7H 1H2, Canada
Trois-Rivieres, Quebec, G9A 3V7, Canada
Study Site - East Montreal, Montreal, Quebec, H1T 2M4, Canada
Study Site - Downtown Montreal, Montreal, Quebec, H2L 4M1, Canada
Study Site - Downtown Montreal, Montreal, Quebec, H2X 3J4, Canada
Study Site - West Montreal, Montreal, Quebec, H3A 1A1, Canada
Study Site - West Montreal, Montreal, Quebec, H3S 1Z1, Canada
Montreal, Quebec, H4A 1S9, Canada
Laval, Quebec, H7G 2E6, Canada
Pointe-Claire, Quebec, H9R 4S3, Canada
Granby, Quebec, J2G 8Z9, Canada
Greenfield Park, Quebec, J4V 2H3, Canada
Croatia
Zagreb, 10 000, Croatia
Zagreb, 10 000, Croatia
Finland
Helsinki, 00029, Finland
Helsinki, 00530, Finland
Lahti, 15800, Finland
Turku, 20100, Finland
Tampere, 33520, Finland
Seinajoki, 60220, Finland
Kuopio, 70100, Finland
Oulu, 90029, Finland
Oulu, 90100, Finland
France
Dijon, 21000, France
Dijon, 21034, France
Besancon, 25030, France
Toulouse, 31403, France
Bordeaux, 33000, France
Montpellier, 34000, France
Rennes, 35700, France
Fourmies Cedex, 59611, France
Lyon, 69437, France
Pierre-Benite, 69495, France
Chalon-sur-Saone, 71100, France
Paris, 75475, France
Paris, 75743, France
Paris, 75877, France
Rouen, 76000, France
Poitiers, 86021, France
Creteil, 94000, France
Germany
Dresden, 01309, Germany
Senftenberg, 01968, Germany
Bautzen, 02625, Germany
Leipzig, 04105, Germany
Grimma, 04668, Germany
Eisleben, 06295, Germany
Hettstedt, 06333, Germany
Dessau, 06842, Germany
Dessau, 06844, Germany
Berlin, 10365, Germany
Berlin, 10713, Germany
Berlin, 10719, Germany
Berlin, 10787, Germany
Berlin, 12099, Germany
Berlin, 12107, Germany
Berlin, 13187, Germany
Berlin, 13347, Germany
Berlin, 13507, Germany
Berlin, 14057, Germany
Strausberg, 15344, Germany
Schwedt, 16303, Germany
Oranienburg, 16515, Germany
Hennigsdorf, 16761, Germany
Bad Doberan, 18209, Germany
Hagenow, 19230, Germany
Wismar, 23970, Germany
Kiel, 24143, Germany
Plon, 24306, Germany
Leer (Ostfriesland), 26789, Germany
Bremervorde, 27432, Germany
Ganderkesee, 27777, Germany
Hildesheim, 31134, Germany
Marburg, 35039, Germany
Gottingen, 37073, Germany
Braunschweig, 38100, Germany
Wolfsburg, 38440, Germany
Magdeburg, 39104, Germany
Wolmirstedt, 39326, Germany
Stendal, 39576, Germany
Gardelegen, 39638, Germany
Monchengladbach, 41061, Germany
Wuppertal, 42103, Germany
Wuppertal, 42275, Germany
Dortmund, 44137, Germany
ESSEN, 45127, Germany
ESSEN, 45395, Germany
Mulheim an der Ruhr, 45475, Germany
Gelsenkirchen, 45894, Germany
Oberhausen, 46045, Germany
Borken, 46325, Germany
Bocholt, 46399, Germany
Duisburg, 47051, Germany
Duisburg, 47179, Germany
Duisburg, 47198, Germany
Moers, 47445, Germany
Kamp-Lintfort, 47475, Germany
Krefeld, 47798, Germany
Krefeld, 47803, German
More Information
Record last reviewed: January 2005
Last Updated: January 12, 2005
Record first received: March 11, 2003
ClinicalTrials.gov Identifier: NCT00056407
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Alcohol Alert #24 Animal Models in Alcohol Research (National Institute on Alcohol Abuse and Alcoholism Publication Distribution Center)
- Animal Research (National Women's Health Information Center)

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