Clinical trial NCT00985738: Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Early Stage Prostate Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-09-28
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Al Barqawi, MD
role: PRINCIPAL_INVESTIGATOR
References: