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

Study Overview
=================
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 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

Official Title
-----------------
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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Dutasteride
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dutasteride<br>The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months. | Drug: Dutasteride<br>* 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.<br>* Other names: Avodart;|
| Placebo Comparator: Placebo<br>The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride. | Other: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume. | The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum. | 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Early Stage Prostate Cancer