Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398281
• Other study ID #: CDR0000513051
• Secondary ID: TJUH-06F-145
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2006
• Last updated: January 9, 2014
• Start date: November 2006
• Est. completion date: September 2012

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.

PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.

Description:

OBJECTIVES:

• Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.

• Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.

• Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.

• Determine the reduction in post-biopsy bleeding after dutasteride in these patients.

• Determine the cost effectiveness of this regimen in these patients.

OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive oral dutasteride once daily on days 1-14.

• Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.

After completion of study procedures, patients are followed at 1 day.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Other known NCT identifiers

• NCT00330057

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

DISEASE CHARACTERISTICS:

• Suspected prostate cancer due to 1 of the following criteria:

• Prior abnormal digital rectal exam

• Elevated prostate-specific antigen (PSA) = 2.6 ng/mL within the past 90 days

• PSA velocity > 0.75 ng/mL/year

• Must be planning to undergo a transrectal ultrasound with biopsy

PATIENT CHARACTERISTICS:

• Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy

• Must not be clinically unstable, severely ill, or moribund

PRIOR CONCURRENT THERAPY:

• More than 30 days since prior biopsy of the prostate

• More than 1 week since prior acetylsalicylic acid or blood thinner

• More than 30 days since prior participation in a clinical trial involving an investigational drug

• No prior therapy for prostate cancer

• No other concurrent 5-alpha reductase inhibitor

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• dutasteride
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kimmel Cancer Center (KCC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of short-term dutasteride in improving prostate cancer detection			No
Primary	Detection rate of prostate cancer			No
Primary	Cost effectiveness of contrast-enhanced ultrasound			No