ARI103094-Follow-Up Study for REDUCE Study Subjects
1 other identifier
observational
2,795
12 countries
267
Brief Summary
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or placebo) through the REDUCE 4 Year study visit \[Visit 10\], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit \[Visit 10P\] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
267 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2010
CompletedJuly 11, 2017
July 1, 2017
1.6 years
April 16, 2009
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
2 years
Secondary Outcomes (1)
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
Study Arms (1)
observational
A follow-up study in adult male subjects who have received investigational
Interventions
A follow-up study in adult male subjects who have received investigational product
Eligibility Criteria
Patients with or without prostate cancer that participated in the REDUCE trial
You may qualify if:
- 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
You may not qualify if:
- Inability/unwillingness to participate in the Follow-Up Study phone calls.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (267)
GSK Investigational Site
Anchorage, Alaska, 99508, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Little Rock, Arkansas, 72211, United States
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
La Mesa, California, CA 91942, United States
GSK Investigational Site
Laguna Hills, California, 92653, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
Poway, California, 92064, United States
GSK Investigational Site
San Bernardino, California, 92404, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Tarzana, California, 91356, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Denver, Colorado, 80211, United States
GSK Investigational Site
Englewood, Colorado, 80113, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
New Britain, Connecticut, 06052, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20307, United States
GSK Investigational Site
Longwood, Florida, 32750, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Pinecrest, Florida, 33156, United States
GSK Investigational Site
Pinellas Park, Florida, 33782, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Galesburg, Illinois, 61401, United States
GSK Investigational Site
Fort Wayne, Indiana, 46825, United States
GSK Investigational Site
Greenwood, Indiana, 46143, United States
GSK Investigational Site
Jeffersonville, Indiana, 47130, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Wichita, Kansas, 67208, United States
GSK Investigational Site
Annapolis, Maryland, 21401, United States
GSK Investigational Site
Towson, Maryland, 21204, United States
GSK Investigational Site
Boston, Massachusetts, 02115, United States
GSK Investigational Site
Watertown, Massachusetts, 02472, United States
GSK Investigational Site
Royal Oak, Michigan, 48073, United States
GSK Investigational Site
Saint Joseph, Michigan, 49085, United States
GSK Investigational Site
Chaska, Minnesota, 55318, United States
GSK Investigational Site
Sartell, Minnesota, 56377, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
West Orange, New Jersey, 07052, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Garden City, New York, 11530, United States
GSK Investigational Site
Great Neck, New York, 11021, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Poughkeepsie, New York, 12601, United States
GSK Investigational Site
Staten Island, New York, 10304, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Columbus, Ohio, 43214, United States
GSK Investigational Site
Sheffield, Ohio, 44035, United States
GSK Investigational Site
Ponca City, Oklahoma, 74601, United States
GSK Investigational Site
Portland, Oregon, 97205, United States
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004, United States
GSK Investigational Site
Lancaster, Pennsylvania, 17604, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19144, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19152, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
State College, Pennsylvania, 16801, United States
GSK Investigational Site
Providence, Rhode Island, 02904, United States
GSK Investigational Site
Myrtle Beach, South Carolina, 29572, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Nashville, Tennessee, 37232 5770, United States
GSK Investigational Site
Norfolk, Virginia, 23502, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Virginia Beach, Virginia, 23454, United States
GSK Investigational Site
Seattle, Washington, 98166, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209, United States
GSK Investigational Site
Av Córdoba 2424, Buenos Aires, 1120, Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, 1437, Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, C1121AAF, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH, Argentina
GSK Investigational Site
Calgary, Alberta, T2V 1P9, Canada
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Kelowna, British Columbia, V1Y 2H4, Canada
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Surrey, British Columbia, V3V 1N1, Canada
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Victoria, British Columbia, V8V 3N1, Canada
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Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Kingston, Ontario, K7L 2V7, Canada
GSK Investigational Site
Newmarket, Ontario, L3X 1W1, Canada
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Oakville, Ontario, L6H 3P1, Canada
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Toronto, Ontario, M1S 4V5, Canada
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Toronto, Ontario, M3B 3S6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Toronto, Ontario, M6A 3B5, Canada
GSK Investigational Site
Waterloo, Ontario, N2J 1C4, Canada
GSK Investigational Site
Chicoutimi, Quebec, G7H 4A3, Canada
GSK Investigational Site
Granby, Quebec, J2G 8Z9, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H3, Canada
GSK Investigational Site
Laval, Quebec, H7G 2E6, Canada
GSK Investigational Site
Montreal, Quebec, H1T 2M4, Canada
GSK Investigational Site
Montreal, Quebec, H2L 4M1, Canada
GSK Investigational Site
Montreal, Quebec, H2X 3J4, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Helsinki, 00029, Finland
GSK Investigational Site
Lappeenranta, 53100, Finland
GSK Investigational Site
Oulu, 90029, Finland
GSK Investigational Site
Oulu, 90100, Finland
GSK Investigational Site
Seinäjoki, 60220, Finland
GSK Investigational Site
Tampere, 33521, Finland
GSK Investigational Site
Auch, 32000, France
GSK Investigational Site
Bourgoin, 38300, France
GSK Investigational Site
Cannes, 06400, France
GSK Investigational Site
Carpentras, 84200, France
GSK Investigational Site
Créteil, 94010, France
GSK Investigational Site
Dijon, 21000, France
GSK Investigational Site
Le Havre, 76600, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Longjumeau, 91161, France
GSK Investigational Site
Lyon, 69437, France
GSK Investigational Site
Mantes-la-Jolie, 78200, France
GSK Investigational Site
Montauban, 82000, France
GSK Investigational Site
Montpellier, 34000, France
GSK Investigational Site
Orléans, 45100, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Paris, 75877, France
GSK Investigational Site
Ploemeur, 56270, France
GSK Investigational Site
Saint-Etienne, 42000, France
GSK Investigational Site
Saint-Martin-d'Hères, 38400, France
GSK Investigational Site
Suresnes, 92151, France
GSK Investigational Site
Toulouse, 31403, France
GSK Investigational Site
Tours, 37044, France
GSK Investigational Site
Troyes, 10000, France
GSK Investigational Site
Backnang, Baden-Wurttemberg, 71522, Germany
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646, Germany
GSK Investigational Site
Neckargemünd, Baden-Wurttemberg, 69151, Germany
GSK Investigational Site
Aichach, Bavaria, 86551, Germany
GSK Investigational Site
Herzogenaurach, Bavaria, 91074, Germany
GSK Investigational Site
Munich, Bavaria, 81927, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90441, Germany
GSK Investigational Site
Planegg, Bavaria, 82152, Germany
GSK Investigational Site
Tirschenreuth, Bavaria, 95643, Germany
GSK Investigational Site
Hagenow, Brandenburg, 19230, Germany
GSK Investigational Site
Hennigsdorf, Brandenburg, 16761, Germany
GSK Investigational Site
Oranienburg, Brandenburg, 16515, Germany
GSK Investigational Site
Senftenberg, Brandenburg, 01968, Germany
GSK Investigational Site
Strausberg, Brandenburg, 15344, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60326, Germany
GSK Investigational Site
Hochheim am Main, Hesse, 65239, Germany
GSK Investigational Site
Marburg, Hesse, 35039, Germany
GSK Investigational Site
Seligenstadt, Hesse, 63500, Germany
GSK Investigational Site
Buchholz, Lower Saxony, 21244, Germany
GSK Investigational Site
Ganderkesee, Lower Saxony, 27777, Germany
GSK Investigational Site
Holzminden, Lower Saxony, 37603, Germany
GSK Investigational Site
Leer, Lower Saxony, 26789, Germany
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, 23970, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50969, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699, Germany
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45883, Germany
GSK Investigational Site
Kempen, North Rhine-Westphalia, 47906, Germany
GSK Investigational Site
Langenfeld, North Rhine-Westphalia, 40764, Germany
GSK Investigational Site
Bad Bergzaben, Rhineland-Palatinate, 76887, Germany
GSK Investigational Site
Bad Schlema, Saxony, 08301, Germany
GSK Investigational Site
Bautzen, Saxony, 02625, Germany
GSK Investigational Site
Chemnitz, Saxony, 09119, Germany
GSK Investigational Site
Döbeln, Saxony, 04720, Germany
GSK Investigational Site
Grimma, Saxony, 04668, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Leipzig, Saxony, 04105, Germany
GSK Investigational Site
Leipzig, Saxony, 04109, Germany
GSK Investigational Site
Leipzig, Saxony, 04179, Germany
GSK Investigational Site
Neustadt, Saxony, 01844, Germany
GSK Investigational Site
Plauen, Saxony, 08523, Germany
GSK Investigational Site
Radebeul, Saxony, 01445, Germany
GSK Investigational Site
Schwarzenberg, Saxony, 08340, Germany
GSK Investigational Site
Wilkau-Haßlau, Saxony, 08112, Germany
GSK Investigational Site
Zwickau, Saxony, 08060, Germany
GSK Investigational Site
Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany
GSK Investigational Site
Gardelegen, Saxony-Anhalt, 39638, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06132, Germany
GSK Investigational Site
Hettstedt, Saxony-Anhalt, 06333, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, 24143, Germany
GSK Investigational Site
Lauenburg, Schleswig-Holstein, 21481, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552, Germany
GSK Investigational Site
Plön, Schleswig-Holstein, 24306, Germany
GSK Investigational Site
Gotha, Thuringia, 99867, Germany
GSK Investigational Site
Ilmenau, Thuringia, 98693, Germany
GSK Investigational Site
Berlin, 10249, Germany
GSK Investigational Site
Berlin, 10369, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 13187, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Hamburg, 22459, Germany
GSK Investigational Site
Athens, 10552, Greece
GSK Investigational Site
Athens, 115 22, Greece
GSK Investigational Site
Heraklion, Crete, 71110, Greece
GSK Investigational Site
Larissa, 41110, Greece
GSK Investigational Site
Periohi Dragana, Alexandroupolis, 68100, Greece
GSK Investigational Site
Rhodes, 85100, Greece
GSK Investigational Site
Thessaloniki, 56429, Greece
GSK Investigational Site
Amsterdam, 1091 AC, Netherlands
GSK Investigational Site
Arnhem, 6815 AD, Netherlands
GSK Investigational Site
Capelle aan den IJssel, 2906 ZC, Netherlands
GSK Investigational Site
Ede, 6716 RP, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Harderwijk, 3844 DG, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Nijmegen, 6525 GA, Netherlands
GSK Investigational Site
Nijmegen, 6532 SZ, Netherlands
GSK Investigational Site
Roermond, 6040 AX, Netherlands
GSK Investigational Site
Rotterdam, 3078 HT, Netherlands
GSK Investigational Site
The Hague, 2512 VA, Netherlands
GSK Investigational Site
The Hague, 2545 CH, Netherlands
GSK Investigational Site
Tilburg, 5022 GC, Netherlands
GSK Investigational Site
Alava, 01004, Spain
GSK Investigational Site
Alcala de Henares (Madrid), Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 8907, Spain
GSK Investigational Site
Bilbao, 48013, Spain
GSK Investigational Site
Ciudad Real, 13600, Spain
GSK Investigational Site
Don Benito (Badajoz), 06400, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Ibiza Town, 07800, Spain
GSK Investigational Site
La Laguna-Tenerife, 38320, Spain
GSK Investigational Site
Logroño, 26006, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28047, Spain
GSK Investigational Site
Manacor (Palma de Mallorca), 07500, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Oviedo, 33006, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
Sagunto, 46520, Spain
GSK Investigational Site
San Sebastián, 20014, Spain
GSK Investigational Site
Sant Joan d'Alacant, 3550, Spain
GSK Investigational Site
Seville, 41003, Spain
GSK Investigational Site
Soria, 42002, Spain
GSK Investigational Site
Valencia, 46009, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Valencia, 46014, Spain
GSK Investigational Site
Valladolid, 47010, Spain
GSK Investigational Site
Borås, SE-503 32, Sweden
GSK Investigational Site
Eskilstuna, SE-633 40, Sweden
GSK Investigational Site
Gävle, SE-801 87, Sweden
GSK Investigational Site
Gothenburg, SE-412 55, Sweden
GSK Investigational Site
Gothenburg, SE-413 46, Sweden
GSK Investigational Site
Karlshamn, SE-374 35, Sweden
GSK Investigational Site
Kristianstad, SE-291 31, Sweden
GSK Investigational Site
Malmo, SE-217 44, Sweden
GSK Investigational Site
Östersund, SE-831 40, Sweden
GSK Investigational Site
Stockholm, SE-117 94, Sweden
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Stockholm, SE-118 83, Sweden
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Umeå, SE-901 85, Sweden
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Vålberg, SE-660 50, Sweden
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Reading, Berkshire, RG2 0TG, United Kingdom
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Exeter, Devon, EX2 5DW, United Kingdom
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Plymouth, Devon, PL6 8DH, United Kingdom
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Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom
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Liverpool, Merseyside, L22 0LG, United Kingdom
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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
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Chichester, Sussex West, PO19 4SE, United Kingdom
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Bristol, BS2 8HW, United Kingdom
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Cardiff, CF14 5GJ, United Kingdom
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Clydebank, Glasgow, G81 2DR, United Kingdom
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Edgbaston, Birmingham, B15 2SQ, United Kingdom
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High Heaton, Newcastle Upon Tyne, NE7 7PN, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
GSK Investigational Site
Waterloo, Liverpool, L22 0LG, United Kingdom
Related Publications (1)
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.
PMID: 23021996BACKGROUND
Related Links
Biospecimen
PART B: Collection of tissue blocks or unstained slides from positive biopsies.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 20, 2009
Study Start
April 9, 2009
Primary Completion
December 1, 2010
Study Completion
December 29, 2010
Last Updated
July 11, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.