ARI103094-Follow-Up Study for REDUCE Study Subjects

ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B:

• 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or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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.

Study Overview

• Status: Completed
• Conditions: Neoplasms, Prostate
• Intervention / Treatment: Drug: dutasteride

• Study Type: Observational
• Enrollment (Actual): 2795

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Av Córdoba 2424, Buenos Aires, Argentina, 1120
      • GSK Investigational Site
    • Capital Federal, Buenos Aires, Argentina, 1437
      • GSK Investigational Site
    • Capital Federal, Buenos Aires, Argentina, C1121AAF
      • GSK Investigational Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
      • GSK Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • GSK Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 2H4
      • GSK Investigational Site
    • Surrey, British Columbia, Canada, V3V 1N1
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8V 3N1
      • GSK Investigational Site
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • GSK Investigational Site
    • Kingston, Ontario, Canada, K7L 2V7
      • GSK Investigational Site
    • Newmarket, Ontario, Canada, L3X 1W1
      • GSK Investigational Site
    • Oakville, Ontario, Canada, L6H 3P1
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M4N 3M5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M1S 4V5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M3B 3S6
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M6A 3B5
      • GSK Investigational Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • GSK Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 4A3
      • GSK Investigational Site
    • Granby, Quebec, Canada, J2G 8Z9
      • GSK Investigational Site
    • Greenfield Park, Quebec, Canada, J4V 2H3
      • GSK Investigational Site
    • Laval, Quebec, Canada, H7G 2E6
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H1T 2M4
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2L 4M1
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2X 3J4
      • GSK Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
• Chile
  • Región Metro De Santiago
    • Santiago, Región Metro De Santiago, Chile
      • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00029
    • GSK Investigational Site
  • Lappeenranta, Finland, 53100
    • GSK Investigational Site
  • Oulu, Finland, 90100
    • GSK Investigational Site
  • Oulu, Finland, 90029
    • GSK Investigational Site
  • Seinajoki, Finland, 60220
    • GSK Investigational Site
  • Tampere, Finland, 33521
    • GSK Investigational Site
• France
  • Auch, France, 32000
    • GSK Investigational Site
  • Bourgoin-Jallieu, France, 38300
    • GSK Investigational Site
  • Cannes, France, 06400
    • GSK Investigational Site
  • Carpentras, France, 84200
    • GSK Investigational Site
  • Créteil cedex, France, 94010
    • GSK Investigational Site
  • Dijon, France, 21000
    • GSK Investigational Site
  • Le Havre, France, 76600
    • GSK Investigational Site
  • Lille Cedex, France, 59037
    • GSK Investigational Site
  • Longjumeau, France, 91161
    • GSK Investigational Site
  • Lyon Cedex 03, France, 69437
    • GSK Investigational Site
  • Mantes La Jolie, France, 78200
    • GSK Investigational Site
  • Montauban, France, 82000
    • GSK Investigational Site
  • Montpellier, France, 34000
    • GSK Investigational Site
  • Orleans, France, 45100
    • GSK Investigational Site
  • Paris Cedex 10, France, 75475
    • GSK Investigational Site
  • Paris Cedex 18, France, 75877
    • GSK Investigational Site
  • Ploemeur, France, 56270
    • GSK Investigational Site
  • Saint Etienne, France, 42000
    • GSK Investigational Site
  • Saint Martin d'Heres, France, 38400
    • GSK Investigational Site
  • Suresnes, France, 92151
    • GSK Investigational Site
  • Toulouse Cedex 4, France, 31403
    • GSK Investigational Site
  • Tours, France, 37044
    • GSK Investigational Site
  • Troyes, France, 10000
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Berlin, Germany, 13187
    • GSK Investigational Site
  • Berlin, Germany, 10249
    • GSK Investigational Site
  • Berlin, Germany, 10369
    • GSK Investigational Site
  • Berlin, Germany, 12627
    • GSK Investigational Site
  • Hamburg, Germany, 22459
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Backnang, Baden-Wuerttemberg, Germany, 71522
      • GSK Investigational Site
    • Bruchsal, Baden-Wuerttemberg, Germany, 76646
      • GSK Investigational Site
    • Neckargemuend, Baden-Wuerttemberg, Germany, 69151
      • GSK Investigational Site
  • Bayern
    • Aichach, Bayern, Germany, 86551
      • GSK Investigational Site
    • Herzogenaurach, Bayern, Germany, 91074
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81927
      • GSK Investigational Site
    • Nuernberg, Bayern, Germany, 90441
      • GSK Investigational Site
    • Planegg, Bayern, Germany, 82152
      • GSK Investigational Site
    • Tirschenreuth, Bayern, Germany, 95643
      • GSK Investigational Site
  • Brandenburg
    • Hagenow, Brandenburg, Germany, 19230
      • GSK Investigational Site
    • Hennigsdorf, Brandenburg, Germany, 16761
      • GSK Investigational Site
    • Oranienburg, Brandenburg, Germany, 16515
      • GSK Investigational Site
    • Senftenberg, Brandenburg, Germany, 01968
      • GSK Investigational Site
    • Strausberg, Brandenburg, Germany, 15344
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60326
      • GSK Investigational Site
    • Hochheim, Hessen, Germany, 65239
      • GSK Investigational Site
    • Marburg, Hessen, Germany, 35039
      • GSK Investigational Site
    • Seligenstadt, Hessen, Germany, 63500
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Wismar, Mecklenburg-Vorpommern, Germany, 23970
      • GSK Investigational Site
  • Niedersachsen
    • Buchholz, Niedersachsen, Germany, 21244
      • GSK Investigational Site
    • Ganderkesee, Niedersachsen, Germany, 27777
      • GSK Investigational Site
    • Holzminden, Niedersachsen, Germany, 37603
      • GSK Investigational Site
    • Leer, Niedersachsen, Germany, 26789
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Erkrath, Nordrhein-Westfalen, Germany, 40699
      • GSK Investigational Site
    • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45883
      • GSK Investigational Site
    • Kempen, Nordrhein-Westfalen, Germany, 47906
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50969
      • GSK Investigational Site
    • Langenfeld, Nordrhein-Westfalen, Germany, 40764
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Bad Bergzabern, Rheinland-Pfalz, Germany, 76887
      • GSK Investigational Site
  • Sachsen
    • Bautzen, Sachsen, Germany, 02625
      • GSK Investigational Site
    • Chemnitz, Sachsen, Germany, 09119
      • GSK Investigational Site
    • Doebeln, Sachsen, Germany, 04720
      • GSK Investigational Site
    • Grimma, Sachsen, Germany, 04668
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04105
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04109
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04179
      • GSK Investigational Site
    • Neustadt, Sachsen, Germany, 01844
      • GSK Investigational Site
    • Plauen, Sachsen, Germany, 08523
      • GSK Investigational Site
    • Radebeul, Sachsen, Germany, 01445
      • GSK Investigational Site
    • Schlema, Sachsen, Germany, 08301
      • GSK Investigational Site
    • Schwarzenberg, Sachsen, Germany, 08340
      • GSK Investigational Site
    • Wilkau-Hasslau, Sachsen, Germany, 08112
      • GSK Investigational Site
    • Zwickau, Sachsen, Germany, 08060
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Eisleben, Sachsen-Anhalt, Germany, 06295
      • GSK Investigational Site
    • Gardelegen, Sachsen-Anhalt, Germany, 39638
      • GSK Investigational Site
    • Halle, Sachsen-Anhalt, Germany, 06132
      • GSK Investigational Site
    • Hettstedt, Sachsen-Anhalt, Germany, 06333
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24143
      • GSK Investigational Site
    • Lauenburg, Schleswig-Holstein, Germany, 21481
      • GSK Investigational Site
    • Luebeck, Schleswig-Holstein, Germany, 23552
      • GSK Investigational Site
    • Ploen, Schleswig-Holstein, Germany, 24306
      • GSK Investigational Site
  • Thueringen
    • Gotha, Thueringen, Germany, 99867
      • GSK Investigational Site
    • Ilmenau, Thueringen, Germany, 98693
      • GSK Investigational Site
• Greece
  • Athens, Greece, 10552
    • GSK Investigational Site
  • Athens, Greece, 115 22
    • GSK Investigational Site
  • Heraklion, Crete, Greece, 71110
    • GSK Investigational Site
  • Larisa, Greece, 41110
    • GSK Investigational Site
  • Periohi Dragana, Alexandroupolis, Greece, 68100
    • GSK Investigational Site
  • Rhodes, Greece, 85100
    • GSK Investigational Site
  • Thessaloniki, Greece, 56429
    • GSK Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • GSK Investigational Site
  • Arnhem, Netherlands, 6815 AD
    • GSK Investigational Site
  • Capelle Aan Den Ijssel, Netherlands, 2906 ZC
    • GSK Investigational Site
  • Den Haag, Netherlands, 2545 CH
    • GSK Investigational Site
  • Den Haag, Netherlands, 2512 VA
    • GSK Investigational Site
  • EDE, Netherlands, 6716 RP
    • GSK Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • GSK Investigational Site
  • Harderwijk, Netherlands, 3844 DG
    • GSK Investigational Site
  • Nieuwegein, Netherlands, 3435 CM
    • GSK Investigational Site
  • Nijmegen, Netherlands, 6525 GA
    • GSK Investigational Site
  • Nijmegen, Netherlands, 6532 SZ
    • GSK Investigational Site
  • Roermond, Netherlands, 6040 AX
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3078 HT
    • GSK Investigational Site
  • Tilburg, Netherlands, 5022 GC
    • GSK Investigational Site
• Spain
  • Alava, Spain, 01004
    • GSK Investigational Site
  • Alcala De Henares (Madrid), Spain
    • GSK Investigational Site
  • Badalona, Spain, 08916
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • Barcelona, Spain, 8907
    • GSK Investigational Site
  • Bilbao, Spain, 48013
    • GSK Investigational Site
  • Ciudad Real, Spain, 13600
    • GSK Investigational Site
  • Don Benito (Badajoz), Spain, 06400
    • GSK Investigational Site
  • Galdakano, Spain, 48960
    • GSK Investigational Site
  • Granada, Spain, 18014
    • GSK Investigational Site
  • Ibiza, Spain, 07800
    • GSK Investigational Site
  • La Laguna-Tenerife, Spain, 38320
    • GSK Investigational Site
  • Logroño, Spain, 26006
    • GSK Investigational Site
  • Madrid, Spain, 28047
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Malaga, Spain, 29010
    • GSK Investigational Site
  • Manacor (Palma de Mallorca), Spain, 07500
    • GSK Investigational Site
  • Oviedo, Spain, 33006
    • GSK Investigational Site
  • Pamplona, Spain, 31008
    • GSK Investigational Site
  • Sagunto, Spain, 46520
    • GSK Investigational Site
  • San Juan De Alicante, Spain, 3550
    • GSK Investigational Site
  • San Sebastián, Spain, 20014
    • GSK Investigational Site
  • Sevilla, Spain, 41003
    • GSK Investigational Site
  • Soria, Spain, 42002
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
  • Valencia, Spain, 46009
    • GSK Investigational Site
  • Valencia, Spain, 46014
    • GSK Investigational Site
  • Valladolid, Spain, 47010
    • GSK Investigational Site
• Sweden
  • Borås, Sweden, SE-503 32
    • GSK Investigational Site
  • Eskilstuna, Sweden, SE-633 40
    • GSK Investigational Site
  • Gävle, Sweden, SE-801 87
    • GSK Investigational Site
  • Göteborg, Sweden, SE-412 55
    • GSK Investigational Site
  • Göteborg, Sweden, SE-413 46
    • GSK Investigational Site
  • Karlshamn, Sweden, SE-374 35
    • GSK Investigational Site
  • Kristianstad, Sweden, SE-291 31
    • GSK Investigational Site
  • Malmö, Sweden, SE-217 44
    • GSK Investigational Site
  • Stockholm, Sweden, SE-117 94
    • GSK Investigational Site
  • Stockholm, Sweden, SE-118 83
    • GSK Investigational Site
  • Umeå, Sweden, SE-901 85
    • GSK Investigational Site
  • Vålberg, Sweden, SE-660 50
    • GSK Investigational Site
  • Östersund, Sweden, SE-831 40
    • GSK Investigational Site
• United Kingdom
  • Bristol, United Kingdom, BS2 8HW
    • GSK Investigational Site
  • Cardiff, United Kingdom, CF14 5GJ
    • GSK Investigational Site
  • Clydebank, Glasgow, United Kingdom, G81 2DR
    • GSK Investigational Site
  • Edgbaston, Birmingham, United Kingdom, B15 2SQ
    • GSK Investigational Site
  • High Heaton, Newcastle upon Tyne, United Kingdom, NE7 7PN
    • GSK Investigational Site
  • Leeds, United Kingdom, LS9 7TF
    • GSK Investigational Site
  • Torquay, United Kingdom, TQ2 7AA
    • GSK Investigational Site
  • Waterloo, Liverpool, United Kingdom, L22 0LG
    • GSK Investigational Site
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 0TG
      • GSK Investigational Site
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • GSK Investigational Site
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • GSK Investigational Site
  • Lancashire
    • Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
      • GSK Investigational Site
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L22 0LG
      • GSK Investigational Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • GSK Investigational Site
  • Sussex West
    • Chichester, Sussex West, United Kingdom, PO19 4SE
      • GSK Investigational Site
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • GSK Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • GSK Investigational Site
    • La Mesa, California, United States, CA 91942
      • GSK Investigational Site
    • Laguna Hills, California, United States, 92653
      • GSK Investigational Site
    • Los Angeles, California, United States, 90073
      • GSK Investigational Site
    • Los Angeles, California, United States, 90048
      • GSK Investigational Site
    • Poway, California, United States, 92064
      • GSK Investigational Site
    • San Bernardino, California, United States, 92404
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
    • Tarzana, California, United States, 91356
      • GSK Investigational Site
    • Torrance, California, United States, 90505
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80211
      • GSK Investigational Site
    • Englewood, Colorado, United States, 80113
      • GSK Investigational Site
    • Longmont, Colorado, United States, 80501
      • GSK Investigational Site
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • GSK Investigational Site
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20307
      • GSK Investigational Site
  • Florida
    • Longwood, Florida, United States, 32750
      • GSK Investigational Site
    • Orlando, Florida, United States, 32803
      • GSK Investigational Site
    • Pinecrest, Florida, United States, 33156
      • GSK Investigational Site
    • Pinellas Park, Florida, United States, 33782
      • GSK Investigational Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • GSK Investigational Site
  • Illinois
    • Galesburg, Illinois, United States, 61401
      • GSK Investigational Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • GSK Investigational Site
    • Greenwood, Indiana, United States, 46143
      • GSK Investigational Site
    • Jeffersonville, Indiana, United States, 47130
      • GSK Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67208
      • GSK Investigational Site
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • GSK Investigational Site
    • Towson, Maryland, United States, 21204
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • GSK Investigational Site
    • Watertown, Massachusetts, United States, 02472
      • GSK Investigational Site
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • GSK Investigational Site
    • Saint Joseph, Michigan, United States, 49085
      • GSK Investigational Site
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • GSK Investigational Site
    • Sartell, Minnesota, United States, 56377
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
    • Springfield, Missouri, United States, 65807
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • GSK Investigational Site
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • GSK Investigational Site
    • Garden City, New York, United States, 11530
      • GSK Investigational Site
    • Great Neck, New York, United States, 11021
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
    • Poughkeepsie, New York, United States, 12601
      • GSK Investigational Site
    • Staten Island, New York, United States, 10304
      • GSK Investigational Site
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • GSK Investigational Site
    • Greenville, North Carolina, United States, 27834
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27607
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43214
      • GSK Investigational Site
    • Sheffield, Ohio, United States, 44035
      • GSK Investigational Site
  • Oklahoma
    • Ponca City, Oklahoma, United States, 74601
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97205
      • GSK Investigational Site
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • GSK Investigational Site
    • Lancaster, Pennsylvania, United States, 17604
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19144
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19152
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • GSK Investigational Site
    • State College, Pennsylvania, United States, 16801
      • GSK Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • GSK Investigational Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • GSK Investigational Site
    • Simpsonville, South Carolina, United States, 29681
      • GSK Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232 5770
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23249
      • GSK Investigational Site
    • Virginia Beach, Virginia, United States, 23454
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98166
      • GSK Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients with or without prostate cancer that participated in the REDUCE trial

Description

Inclusion Criteria: PART A

• Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria is eligible for Part A, 2 Year Observational Follow-Up Study:
• 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

Exclusion Criteria: PART A Subjects meeting the following criterion must not be enrolled in Part A of the study

• Inability/unwillingness to participate in the Follow-Up Study phone calls.

Inclusion Criteria: PART B

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: PART B

• The exclusion criterion only applies to Part A, the 2 year Observational Follow-Up Study. There are no exclusion criteria for Part B, Prostate Biopsy Tissue Study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observational; A follow-up study in adult male subjects who have received investigational	Drug: dutasteride; A follow-up study in adult male subjects who have received investigational product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To collect and summarize data on Adverse Events for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.	2 years

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: April 9, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 29, 2010

Study Registration Dates

• First Submitted: April 16, 2009
• First Submitted That Met QC Criteria: April 16, 2009
• First Posted (Estimate): April 20, 2009

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Prostate Cancer; Benign Prostatic Hyperplasia
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: 103094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: 103094
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register