Clinical trial NCT00883909: ARI103094-Follow-Up Study for REDUCE Study Subjects
Official title: ARI103094-Follow-Up Study for REDUCE Study Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Prostate
Keywords: Prostate Cancer
Benign Prostatic Hyperplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 2795
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with or without prostate cancer that participated in the REDUCE trial

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placebo) through the REDUCE 4 Year study visit \[Visit 10\], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit \[Visit 10P\] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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


Eligibility criteria: 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.

Primary outcomes:
measure: To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
timeFrame: 2 years
Secondary outcomes:
measure: To collect and summarize data on Adverse Events for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
timeFrame: 2 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: GSK Investigational Site
state: Alaska
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: La Mesa
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facility: GSK Investigational Site
state: California
city: Laguna Hills
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facility: GSK Investigational Site
state: California
city: Los Angeles
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facility: GSK Investigational Site
state: California
city: Los Angeles
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facility: GSK Investigational Site
state: California
city: Poway
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facility: GSK Investigational Site
state: California
city: San Bernardino
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state: California
city: San Diego
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state: California
city: Tarzana
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facility: GSK Investigational Site
state: California
city: Torrance
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state: California
city: Denver
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facility: GSK Investigational Site
state: Colorado
city: Englewood
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state: Colorado
city: Longmont
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state: Colorado
city: New Britain
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facility: GSK Investigational Site
state: Connecticut
city: Washington, D.C.
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facility: GSK Investigational Site
state: District of Columbia
city: Longwood
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facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Pinecrest
country: United States
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state: Florida
city: Pinellas Park
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city: Coeur d'Alene
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state: Idaho
city: Galesburg
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state: Illinois
city: Fort Wayne
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city: Greenwood
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city: Jeffersonville
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city: Overland Park
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state: Maryland
city: Towson
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city: Boston
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state: Massachusetts
city: Watertown
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city: Royal Oak
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state: Michigan
city: Saint Joseph
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city: Sartell
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city: Saint Louis
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state: Missouri
city: Omaha
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state: Nebraska
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city: State College
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state: Rhode Island
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state: South Carolina
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state: South Carolina
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state: Virginia
city: Richmond
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state: Virginia
city: Virginia Beach
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state: Washington
city: Milwaukee
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state: Wisconsin
city: Av Córdoba 2424
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
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state: Buenos Aires
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Kelowna
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facility: GSK Investigational Site
state: British Columbia
city: Surrey
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state: British Columbia
city: Victoria
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state: British Columbia
city: Burlington
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state: Ontario
city: Kingston
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state: Ontario
city: Newmarket
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state: Ontario
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state: Ontario
city: Toronto
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state: Ontario
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state: Ontario
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state: Quebec
city: Granby
country: Canada
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state: Quebec
city: Greenfield Park
country: Canada
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state: Quebec
city: Laval
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state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Montreal
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state: Quebec
city: Montreal
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state: Quebec
city: Pointe-Claire
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state: Quebec
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Lappeenranta
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
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city: Oulu
country: Finland
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city: Seinajoki
country: Finland
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city: Tampere
country: Finland
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city: Auch
country: France
facility: GSK Investigational Site
city: Bourgoin-Jallieu
country: France
facility: GSK Investigational Site
city: Cannes
country: France
facility: GSK Investigational Site
city: Carpentras
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city: Créteil cedex
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city: Dijon
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city: Lille Cedex
country: France
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city: Lyon Cedex 03
country: France
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city: Mantes La Jolie
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city: Orleans
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city: Paris Cedex 10
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city: Paris Cedex 18
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city: Saint Martin d'Heres
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city: Suresnes
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city: Toulouse Cedex 4
country: France
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city: Tours
country: France
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city: Troyes
country: France
facility: GSK Investigational Site
city: Backnang
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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facility: GSK Investigational Site
state: Bayern
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state: Bayern
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facility: GSK Investigational Site
state: Bayern
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state: Bayern
city: Planegg
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facility: GSK Investigational Site
state: Bayern
city: Tirschenreuth
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facility: GSK Investigational Site
state: Bayern
city: Hagenow
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facility: GSK Investigational Site
state: Brandenburg
city: Hennigsdorf
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Oranienburg
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facility: GSK Investigational Site
state: Brandenburg
city: Senftenberg
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Strausberg
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hochheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Marburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Seligenstadt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wismar
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Buchholz
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Ganderkesee
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Holzminden
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Leer
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Erkrath
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kempen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Langenfeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bad Bergzabern
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Eisleben
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Gardelegen
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Hettstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Bautzen
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Doebeln
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Grimma
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
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facility: GSK Investigational Site
state: Sachsen
city: Neustadt
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state: Sachsen
city: Plauen
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state: Sachsen
city: Radebeul
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state: Sachsen
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facility: GSK Investigational Site
state: Sachsen
city: Schwarzenberg
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facility: GSK Investigational Site
state: Sachsen
city: Wilkau-Hasslau
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facility: GSK Investigational Site
state: Sachsen
city: Zwickau
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facility: GSK Investigational Site
state: Sachsen
city: Kiel
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facility: GSK Investigational Site
state: Schleswig-Holstein
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country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Ploen
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facility: GSK Investigational Site
state: Schleswig-Holstein
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facility: GSK Investigational Site
state: Thueringen
city: Ilmenau
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facility: GSK Investigational Site
state: Thueringen
city: Berlin
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facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
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facility: GSK Investigational Site
city: Athens
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city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
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facility: GSK Investigational Site
city: Larisa
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facility: GSK Investigational Site
city: Periohi Dragana, Alexandroupolis
country: Greece
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city: Rhodes
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city: Thessaloniki
country: Greece
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city: Amsterdam
country: Netherlands
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city: Arnhem
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city: Capelle Aan Den Ijssel
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city: Den Haag
country: Netherlands
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city: EDE
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city: Eindhoven
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city: Harderwijk
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city: Nieuwegein
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city: Nijmegen
country: Netherlands
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city: Nijmegen
country: Netherlands
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city: Roermond
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Tilburg
country: Netherlands
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city: Alava
country: Spain
facility: GSK Investigational Site
city: Alcala De Henares (Madrid)
country: Spain
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city: Badalona
country: Spain
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city: Barcelona
country: Spain
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city: Barcelona
country: Spain
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city: Barcelona
country: Spain
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city: Bilbao
country: Spain
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city: Ciudad Real
country: Spain
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city: Don Benito (Badajoz)
country: Spain
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city: Galdakano
country: Spain
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city: Granada
country: Spain
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city: Ibiza
country: Spain
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city: La Laguna-Tenerife
country: Spain
facility: GSK Investigational Site
city: Logroño
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
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city: Malaga
country: Spain
facility: GSK Investigational Site
city: Manacor (Palma de Mallorca)
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
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city: Pamplona
country: Spain
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city: Sagunto
country: Spain
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city: San Juan De Alicante
country: Spain
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city: San Sebastián
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
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city: Soria
country: Spain
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city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Borås
country: Sweden
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Gävle
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Karlshamn
country: Sweden
facility: GSK Investigational Site
city: Kristianstad
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Vålberg
country: Sweden
facility: GSK Investigational Site
city: Östersund
country: Sweden
facility: GSK Investigational Site
city: Reading
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Exeter
country: United Kingdom
facility: GSK Investigational Site
state: Devon
city: Plymouth
country: United Kingdom
facility: GSK Investigational Site
state: Devon
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: Chichester
country: United Kingdom
facility: GSK Investigational Site
state: Sussex West
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Clydebank, Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: High Heaton, Newcastle upon Tyne
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Torquay
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.