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

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: GlaxoSmithKline
• Treatments: Dutasteride

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