Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Dutasteride; Placebo
Intervention description: 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.; 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 MeSH terms: Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: Male
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Early Stage Prostate Cancer

Summary:

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

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