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

This study is ongoing, but not recruiting participants.

First Received: March 11, 2003 Last Updated: May 7, 2009 History of Changes

Sponsored by:	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	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, 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.

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

Estimated Enrollment:	8000
Study Start Date:	March 2003

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 814 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ARI40006
Study First Received:	March 11, 2003
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00056407 History of Changes
Health Authority:	United States: Food and Drug Administration; Sweden: Medical Products Agency; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Prostate cancer prevention
BPH
enlarged prostate

PSA
prostate cancer
prostate

Study placed in the following topic categories:

Dutasteride
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

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 July 06, 2009