Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2795 participants
OBSERVATIONAL
2009-04-09
2010-12-29
Brief Summary
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* REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study. Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as follows: (1) REDUCE subjects who completed treatment with investigational product (dutasteride or placebo) through the REDUCE 4 Year study visit \[Visit 10\], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit \[Visit 10P\] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit 10). The objective of this observational study for eligible REDUCE subjects is to collect and summarize data on prostate cancer (the incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled study, REDUCE.
* REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE study.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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observational
A follow-up study in adult male subjects who have received investigational
dutasteride
A follow-up study in adult male subjects who have received investigational product
Interventions
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dutasteride
A follow-up study in adult male subjects who have received investigational product
Eligibility Criteria
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Inclusion Criteria
* Completed 4 years on Investigational Product through the REDUCE 4 Year study visit (Visit 10) OR
* Was diagnosed with prostate cancer during the REDUCE study, discontinued Investigational Product (IP) but participated in REDUCE Prostate Cancer Follow-Up visits through the 4 Year study visit (Visit 10P) OR
* Withdrew from REDUCE study visit participation and IP (for any reasons) but participated in REDUCE Follow-Up phone calls every 6 months through the 4 Year phone call
Subjects eligible for enrolment in Part B of the study must meet the following criteria:
* Any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the REDUCE Study, regardless of when their REDUCE study participation ended.
Exclusion Criteria
50 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Poway, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Longmont, Colorado, United States
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New Britain, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Longwood, Florida, United States
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Orlando, Florida, United States
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Pinecrest, Florida, United States
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Pinellas Park, Florida, United States
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Coeur d'Alene, Idaho, United States
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Galesburg, Illinois, United States
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Fort Wayne, Indiana, United States
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Greenwood, Indiana, United States
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Jeffersonville, Indiana, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Annapolis, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Watertown, Massachusetts, United States
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Royal Oak, Michigan, United States
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Saint Joseph, Michigan, United States
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Chaska, Minnesota, United States
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Sartell, Minnesota, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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West Orange, New Jersey, United States
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Albany, New York, United States
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Garden City, New York, United States
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Great Neck, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Staten Island, New York, United States
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Syracuse, New York, United States
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Cary, North Carolina, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Sheffield, Ohio, United States
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Ponca City, Oklahoma, United States
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Portland, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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State College, Pennsylvania, United States
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Providence, Rhode Island, United States
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Myrtle Beach, South Carolina, United States
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Simpsonville, South Carolina, United States
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Nashville, Tennessee, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Av Córdoba 2424, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Victoria, British Columbia, Canada
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Burlington, Ontario, Canada
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Kingston, Ontario, Canada
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Newmarket, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Granby, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Santiago, Región Metro de Santiago, Chile
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Helsinki, , Finland
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Lappeenranta, , Finland
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Oulu, , Finland
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Oulu, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Auch, , France
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Bourgoin, , France
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Cannes, , France
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Carpentras, , France
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Créteil, , France
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Dijon, , France
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Le Havre, , France
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Lille, , France
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Longjumeau, , France
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Lyon, , France
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Mantes-la-Jolie, , France
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Montauban, , France
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Montpellier, , France
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Orléans, , France
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Paris, , France
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Paris, , France
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Ploemeur, , France
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Saint-Etienne, , France
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Saint-Martin-d'Hères, , France
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Suresnes, , France
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Toulouse, , France
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Tours, , France
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Troyes, , France
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Backnang, Baden-Wurttemberg, Germany
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Bruchsal, Baden-Wurttemberg, Germany
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Neckargemünd, Baden-Wurttemberg, Germany
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Aichach, Bavaria, Germany
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Herzogenaurach, Bavaria, Germany
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Munich, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Planegg, Bavaria, Germany
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Tirschenreuth, Bavaria, Germany
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Hagenow, Brandenburg, Germany
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Hennigsdorf, Brandenburg, Germany
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Oranienburg, Brandenburg, Germany
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Senftenberg, Brandenburg, Germany
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Strausberg, Brandenburg, Germany
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Frankfurt am Main, Hesse, Germany
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Hochheim am Main, Hesse, Germany
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Marburg, Hesse, Germany
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Seligenstadt, Hesse, Germany
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Buchholz, Lower Saxony, Germany
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Ganderkesee, Lower Saxony, Germany
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Holzminden, Lower Saxony, Germany
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Leer, Lower Saxony, Germany
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Wismar, Mecklenburg-Vorpommern, Germany
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Cologne, North Rhine-Westphalia, Germany
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Erkrath, North Rhine-Westphalia, Germany
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Gelsenkirchen, North Rhine-Westphalia, Germany
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Kempen, North Rhine-Westphalia, Germany
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Langenfeld, North Rhine-Westphalia, Germany
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Bad Bergzaben, Rhineland-Palatinate, Germany
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Bad Schlema, Saxony, Germany
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Bautzen, Saxony, Germany
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Chemnitz, Saxony, Germany
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Döbeln, Saxony, Germany
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Grimma, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Neustadt, Saxony, Germany
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Plauen, Saxony, Germany
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Radebeul, Saxony, Germany
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Schwarzenberg, Saxony, Germany
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Wilkau-Haßlau, Saxony, Germany
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Zwickau, Saxony, Germany
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Eisleben Lutherstadt, Saxony-Anhalt, Germany
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Gardelegen, Saxony-Anhalt, Germany
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Halle, Saxony-Anhalt, Germany
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Hettstedt, Saxony-Anhalt, Germany
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Kiel, Schleswig-Holstein, Germany
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Lauenburg, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Plön, Schleswig-Holstein, Germany
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Gotha, Thuringia, Germany
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Ilmenau, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Heraklion, Crete, , Greece
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Larissa, , Greece
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Periohi Dragana, Alexandroupolis, , Greece
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Rhodes, , Greece
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Thessaloniki, , Greece
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Capelle aan den IJssel, , Netherlands
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Ede, , Netherlands
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Eindhoven, , Netherlands
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Harderwijk, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Nijmegen, , Netherlands
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Roermond, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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The Hague, , Netherlands
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Tilburg, , Netherlands
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Alava, , Spain
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Alcala de Henares (Madrid), , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Ciudad Real, , Spain
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Don Benito (Badajoz), , Spain
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Galdakano, , Spain
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Granada, , Spain
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Ibiza Town, , Spain
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La Laguna-Tenerife, , Spain
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Logroño, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Manacor (Palma de Mallorca), , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Pamplona, , Spain
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Sagunto, , Spain
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San Sebastián, , Spain
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Sant Joan d'Alacant, , Spain
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Seville, , Spain
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Soria, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Borås, , Sweden
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Eskilstuna, , Sweden
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Gävle, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Karlshamn, , Sweden
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Kristianstad, , Sweden
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Malmo, , Sweden
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Östersund, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Vålberg, , Sweden
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Reading, Berkshire, United Kingdom
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Exeter, Devon, United Kingdom
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Plymouth, Devon, United Kingdom
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Buckshaw Village, Chorley, Lancashire, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Chichester, Sussex West, United Kingdom
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Bristol, , United Kingdom
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Cardiff, , United Kingdom
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Clydebank, Glasgow, , United Kingdom
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Edgbaston, Birmingham, , United Kingdom
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High Heaton, Newcastle Upon Tyne, , United Kingdom
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Leeds, , United Kingdom
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Torquay, , United Kingdom
GSK Investigational Site
Waterloo, Liverpool, , United Kingdom
Countries
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References
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Grubb RL, Andriole GL, Somerville MC, Mahoney C, Manyak MJ, Castro R. The REDUCE Follow-Up Study: low rate of new prostate cancer diagnoses observed during a 2-year, observational, followup study of men who participated in the REDUCE trial. J Urol. 2013 Mar;189(3):871-7. doi: 10.1016/j.juro.2012.09.099. Epub 2012 Sep 25.
Study Documents
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Document Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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103094
Identifier Type: -
Identifier Source: org_study_id
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