ARI103094-Follow-Up Study for REDUCE Study Subjects

Completed

Conditions studied: Neoplasms, Prostate

In brief

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placebo) through the REDUCE 4 Year study visit \[Visit 10\], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit \[Visit 10P\] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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

Key facts

Study ID

NCT00883909

Run by

GlaxoSmithKline

People needed

2795

Starts

2009-04-09

Expected to finish

2010-12-29

Last updated by the study team

2017-07-11

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — La Mesa, California, United States
• GSK Investigational Site — Laguna Hills, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Poway, California, United States
• GSK Investigational Site — San Bernardino, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Englewood, Colorado, United States
• GSK Investigational Site — Longmont, Colorado, United States
• GSK Investigational Site — New Britain, Connecticut, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Longwood, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Pinecrest, Florida, United States
• GSK Investigational Site — Pinellas Park, Florida, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Galesburg, Illinois, United States
• GSK Investigational Site — Fort Wayne, Indiana, United States
• GSK Investigational Site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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