ARI103094-Follow-Up Study for REDUCE Study Subjects

Neoplasms, Prostate Clinical Trial

Official title:

ARI103094-Follow-Up Study for REDUCE Study Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883909
• Other study ID #: 103094
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: July 6, 2017
• Start date: April 9, 2009
• Est. completion date: December 29, 2010

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2795
• Est. completion date: December 29, 2010
• Est. primary completion date: December 1, 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Prostate
• Prostatic Neoplasms

Intervention

Drug:
• dutasteride
A follow-up study in adult male subjects who have received investigational product

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Av Córdoba 2424	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Chicoutimi	Quebec
Canada	GSK Investigational Site	Granby	Quebec
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Newmarket	Ontario
Canada	GSK Investigational Site	Oakville	Ontario
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Waterloo	Ontario
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Lappeenranta
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Auch
France	GSK Investigational Site	Bourgoin-Jallieu
France	GSK Investigational Site	Cannes
France	GSK Investigational Site	Carpentras
France	GSK Investigational Site	Créteil cedex
France	GSK Investigational Site	Dijon
France	GSK Investigational Site	Le Havre
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Longjumeau
France	GSK Investigational Site	Lyon Cedex 03
France	GSK Investigational Site	Mantes La Jolie
France	GSK Investigational Site	Montauban
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Orleans
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Ploemeur
France	GSK Investigational Site	Saint Etienne
France	GSK Investigational Site	Saint Martin d'Heres
France	GSK Investigational Site	Suresnes
France	GSK Investigational Site	Toulouse Cedex 4
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Troyes
Germany	GSK Investigational Site	Aichach	Bayern
Germany	GSK Investigational Site	Backnang	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bad Bergzabern	Rheinland-Pfalz
Germany	GSK Investigational Site	Bautzen	Sachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Buchholz	Niedersachsen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Eisleben	Sachsen-Anhalt
Germany	GSK Investigational Site	Erkrath	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Ganderkesee	Niedersachsen
Germany	GSK Investigational Site	Gardelegen	Sachsen-Anhalt
Germany	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gotha	Thueringen
Germany	GSK Investigational Site	Grimma	Sachsen
Germany	GSK Investigational Site	Hagenow	Brandenburg
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hennigsdorf	Brandenburg
Germany	GSK Investigational Site	Herzogenaurach	Bayern
Germany	GSK Investigational Site	Hettstedt	Sachsen-Anhalt
Germany	GSK Investigational Site	Hochheim	Hessen
Germany	GSK Investigational Site	Holzminden	Niedersachsen
Germany	GSK Investigational Site	Ilmenau	Thueringen
Germany	GSK Investigational Site	Kempen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Langenfeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lauenburg	Schleswig-Holstein
Germany	GSK Investigational Site	Leer	Niedersachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neckargemuend	Baden-Wuerttemberg
Germany	GSK Investigational Site	Neustadt	Sachsen
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oranienburg	Brandenburg
Germany	GSK Investigational Site	Planegg	Bayern
Germany	GSK Investigational Site	Plauen	Sachsen
Germany	GSK Investigational Site	Ploen	Schleswig-Holstein
Germany	GSK Investigational Site	Radebeul	Sachsen
Germany	GSK Investigational Site	Schlema	Sachsen
Germany	GSK Investigational Site	Schwarzenberg	Sachsen
Germany	GSK Investigational Site	Seligenstadt	Hessen
Germany	GSK Investigational Site	Senftenberg	Brandenburg
Germany	GSK Investigational Site	Strausberg	Brandenburg
Germany	GSK Investigational Site	Tirschenreuth	Bayern
Germany	GSK Investigational Site	Wilkau-Hasslau	Sachsen
Germany	GSK Investigational Site	Wismar	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Zwickau	Sachsen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Heraklion, Crete
Greece	GSK Investigational Site	Larisa
Greece	GSK Investigational Site	Periohi Dragana, Alexandroupolis
Greece	GSK Investigational Site	Rhodes
Greece	GSK Investigational Site	Thessaloniki
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Arnhem
Netherlands	GSK Investigational Site	Capelle Aan Den Ijssel
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	EDE
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Nieuwegein
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Roermond
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Tilburg
Spain	GSK Investigational Site	Alava
Spain	GSK Investigational Site	Alcala De Henares (Madrid)
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Bilbao
Spain	GSK Investigational Site	Ciudad Real
Spain	GSK Investigational Site	Don Benito (Badajoz)
Spain	GSK Investigational Site	Galdakano
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Ibiza
Spain	GSK Investigational Site	La Laguna-Tenerife
Spain	GSK Investigational Site	Logroño
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Manacor (Palma de Mallorca)
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	Pamplona
Spain	GSK Investigational Site	Sagunto
Spain	GSK Investigational Site	San Juan De Alicante
Spain	GSK Investigational Site	San Sebastián
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Soria
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Sweden	GSK Investigational Site	Borås
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Gävle
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Karlshamn
Sweden	GSK Investigational Site	Kristianstad
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Östersund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Umeå
Sweden	GSK Investigational Site	Vålberg
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Cardiff
United Kingdom	GSK Investigational Site	Chichester	Sussex West
United Kingdom	GSK Investigational Site	Clydebank, Glasgow
United Kingdom	GSK Investigational Site	Edgbaston, Birmingham
United Kingdom	GSK Investigational Site	Exeter	Devon
United Kingdom	GSK Investigational Site	High Heaton, Newcastle upon Tyne
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Liverpool	Merseyside
United Kingdom	GSK Investigational Site	Nottingham	Nottinghamshire
United Kingdom	GSK Investigational Site	Plymouth	Devon
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Torquay
United Kingdom	GSK Investigational Site	Waterloo, Liverpool
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Anchorage	Alaska
United States	GSK Investigational Site	Annapolis	Maryland
United States	GSK Investigational Site	Bala-Cynwyd	Pennsylvania
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Chaska	Minnesota
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Coeur d'Alene	Idaho
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Fort Wayne	Indiana
United States	GSK Investigational Site	Galesburg	Illinois
United States	GSK Investigational Site	Garden City	New York
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Greenwood	Indiana
United States	GSK Investigational Site	Jeffersonville	Indiana
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	La Mesa	California
United States	GSK Investigational Site	Laguna Hills	California
United States	GSK Investigational Site	Lancaster	Pennsylvania
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Longwood	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Myrtle Beach	South Carolina
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Britain	Connecticut
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pinecrest	Florida
United States	GSK Investigational Site	Pinellas Park	Florida
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Ponca City	Oklahoma
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Poughkeepsie	New York
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Royal Oak	Michigan
United States	GSK Investigational Site	Saint Joseph	Michigan
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Bernardino	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Sartell	Minnesota
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Sheffield	Ohio
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	State College	Pennsylvania
United States	GSK Investigational Site	Staten Island	New York
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Washington, D.C.	District of Columbia
United States	GSK Investigational Site	Watertown	Massachusetts
United States	GSK Investigational Site	West Orange	New Jersey
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Finland,  France,  Germany,  Greece,  Netherlands,  Spain,  Sweden,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.		2 years
Secondary	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

External Links

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