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: November 30, 2016
Last verified: November 2016
  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or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit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 ]

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 ]

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   (Adult, Senior)
Sexes 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

  Show 267 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 103094
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00883909     History of Changes
Other Study ID Numbers: 103094 
Study First Received: April 16, 2009
Last Updated: November 30, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Prostate Cancer
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 19, 2017