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

Prostate Cancer Clinical Trial

— Dutasteride  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00985738
• Other study ID #: 09-0247
• Status: Terminated
• Phase: Phase 2
• First received: September 11, 2009
• Last updated: January 15, 2013
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: September 2009
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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 5a-reductase inhibitors medications within the past 12 months before enrollment.

• Known hypersensitivity to dutasteride, or other 5a-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dutasteride
Dutasteride (Avodart) 0.5 mg QD. Drug initiation 3 months before 3 D mapping biopsy.

Other:
• placebo

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 Months	Yes
Secondary	To determine the effect of daily intake of Dutasteride 0.5 mg (90 days) on prostate volume and total PSA level in patients with prostate size >15 grams before undergoing 3D mapping biopsy.		24 Months	Yes

External Links

•   Link