Neoplasms, Prostate Clinical Trial
Official title:
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subjects who developed prostate cancer, were withdrawn from investigational product and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10P] or (3) REDUCE subjects who were withdrawn from investigational product and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.
n/a
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