Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic	Active	18 to 80	NCI	TJUH-06F-145 NCT00398281

Objectives

1. Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
2. Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
3. Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
4. Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
5. Determine the cost effectiveness of this regimen in these patients.

Entry Criteria

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

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

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

Expected Enrollment

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

Outcomes

Efficacy of short-term dutasteride in improving prostate cancer detection
Detection rate of prostate cancer
Cost effectiveness of contrast-enhanced ultrasound

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.

Trial Contact Information

Trial Lead Organizations

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Ethan Halpern, MD, Principal investigator		Ph: 215-955-5345; 800-533-3669 Email: ethan.halpern@jefferson.edu

U.S.A.
Pennsylvania
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084

Registry Information
Official Title		Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
Trial Start Date		2006-11-01
Trial Completion Date		2010-07-31 (estimated)
Registered in ClinicalTrials.gov		NCT00398281
Date Submitted to PDQ		2006-10-10
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA118003

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