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
- 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
- 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
- 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