Status:
TERMINATED
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00985738
Start Date
September 1 2009
End Date
January 1 2013
Last Update
May 17 2016
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045