Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

NCT ID: NCT00985738

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.

Detailed Description

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 by having a 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dutasteride

The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.

Group Type: EXPERIMENTAL

Dutasteride

Intervention Type: DRUG

Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.

Placebo

The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.

Interventions

Dutasteride

Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.

Intervention Type: DRUG

Placebo

The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.

Intervention Type: OTHER

Other Intervention Names

Avodart

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Al Barqawi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Related Links

http://www.alprostate.com

The link above provides detail about the Primary Investigator (PI- Al Barqawi MD FRCS) and his research on prostate cancer. In addition, this website includes the PI's resume and publications.

Other Identifiers

09-0247.cc

Identifier Type: -

Identifier Source: org_study_id