Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer - Full Text View

Sponsor:	University of Colorado, Denver
Collaborator:	GlaxoSmithKline
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00985738

Purpose

This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

Condition	Intervention	Phase
Prostate Cancer	Drug: Dutasteride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Placebo-Controlled Double-Blind Clinical Trial to Assess the Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage 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 University of Colorado, Denver:

Primary Outcome Measures:

To determine the effect of short-term intake of daily dutasteride prostate cancer volume, distribution within the gland and Gleason score sum in patients in comparison to placebo after adjusting for changes in prostate gland volume. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the effect of daily intake of Dutasteride 0.5 mg (90 days) on prostate volume and total PSA level in patients with prostate size >15 grams before undergoing 3D mapping biopsy. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dutasteride: Experimental Dutasteride (Avodart) 0.5 mg QD. Drug initiation 3 months before 3 D mapping biopsy.	Drug: Dutasteride Dutasteride (Avodart) 0.5 mg QD. Drug initiation 3 months before 3 D mapping biopsy.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

40-85 year old males
Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.
Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.
Patient will read, understand and sign the informed consent agreement
Patients must have a life expectancy of at least one year.
Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4
Percentage positive core rate < 50% based on sextant or extended biopsy technique.
Prostate Volume (PV) >15 grams.
Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA> 10 ng.dl before initiation of the study drug

Exclusion Criteria:

Any 5α-reductase inhibitors medications within the past 12 months before enrollment.
Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.
Anticipated blood donation within the next 90 days.
Serum PSA levels of >20ng/dl.
Clinical evidence of metastatic prostate cancer.
Two documented urinary tract infections in the past year
CHF, MI (within 6 months) or other symptomatic CVS disease
Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)
Enrollment in other studies for any disease in the past 30 days
Significant urinary incontinence
Diagnosis of cancer that in not considered cured, except BCC of skin
Prior transurethral resection of the prostate with a large tissue defect.
History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
Previous or concurrent radiotherapy, hormonal therapy or chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985738

Contacts

Contact: Al Barqawi, MD	720-848-0568	Al.Barqawi@UCDenver.edu
Contact: Colin O'Donnell, BS	303-724-7512	Colin.ODonnell@UCDenver.edu

Locations

United States, Colorado
University of Colorado Hospital	Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Al Barqawi, MD

Sponsors and Collaborators

University of Colorado, Denver

GlaxoSmithKline

Investigators

Principal Investigator:

Al Barqawi, MD

University of Colorado, Denver

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Colorado Denver ( Al Barqawi, MD )
Study ID Numbers:	COMIRB#: 09-0247
Study First Received:	September 11, 2009
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00985738 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:

Prostate Cancer
Early Stage Prostate Cancer

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 February 08, 2010