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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00985738

Run by

University of Colorado, Denver

People needed

16

Starts

2009-09-01

Expected to finish

2013-01-01

Last updated by the study team

2016-05-17

Who can join

Age: 40 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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