"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00056407

Purpose

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Condition	Intervention	Phase
Prostate Cancer	Drug: Dutasteride Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Daily for Four Years to Reduce the Risk of Biopsy-Dectectable Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Biopsy-detectable prostate cancer after 2 and 4 years of treatment. [ Time Frame: 2 and 4 years ]

Secondary Outcome Measures:

Gleason Grade at diagnosis. Occurence and quantity of HGPIN at biopsy. Percentage of core involved at diagnosis; Number of cancer positive cores

Enrollment:	8263
Study Start Date:	March 2003
Study Completion Date:	May 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Arm: Placebo Comparator Eligible subjects will complete a 4-week placebo run-in followed by randomization to either 0.5mg dutasteride or matched placebo in a 1:1 ratio.	Drug: Placebo After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug orally for up to 4 years.
dustasteride arm: Experimental Eligible subjects will complete a 4-week placebo run-in followed by randomization to either 0.5mg dutasteride or matched placebo in a 1:1 ratio. Randomization will be stratified by center.	Drug: Dutasteride After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Informed consent to participate in study.
Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
Ability and will to participate in study for 4 years.

Exclusion criteria:

More than one previous negative prostate biopsy.
History of prostate cancer.
Previous prostate surgery.
Inability to urinate requiring the need of a catheter during the previous 2 years.
Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
Any unstable serious medical condition.
Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056407

Show 816 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ARI40006
Study First Received:	March 11, 2003
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00056407 History of Changes
Health Authority:	Canada: Health Canada; Sweden: Medical Products Agency; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Prostate cancer prevention
BPH
enlarged prostate

PSA
prostate cancer
prostate

Additional relevant MeSH terms:

Dutasteride
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male

Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009