ARI103094-Follow-Up Study for REDUCE Study Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00883909
First received: April 16, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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

Condition Intervention
Neoplasms, Prostate
Drug: dutasteride

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: ARI103094-Follow-Up Study for REDUCE Study Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To collect and summarize data on Adverse Events for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

PART B: Collection of tissue blocks or unstained slides from positive biopsies.


Enrollment: 2795
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
observational
A follow-up study in adult male subjects who have received investigational
Drug: dutasteride
A follow-up study in adult male subjects who have received investigational product

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with or without prostate cancer that participated in the REDUCE trial

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883909

Locations
Argentina
GSK Investigational Site
Av Córdoba 2424, Buenos Aires, Argentina, 1120
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1121AAF
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, 1437
France
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Mantes La Jolie, France, 78200
Greece
GSK Investigational Site
Athens, Greece, 10552
GSK Investigational Site
Heraklion, Crete, Greece, 71110
GSK Investigational Site
Larisa, Greece, 41110
GSK Investigational Site
Periohi Dragana, Alexandroupolis, Greece, 68100
GSK Investigational Site
Rhodes, Greece, 85100
GSK Investigational Site
Thessaloniki, Greece, 56429
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00883909     History of Changes
Other Study ID Numbers: 103094
Study First Received: April 16, 2009
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Prostate Cancer
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014