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Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00398281
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : January 10, 2014
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: dutasteride Other: placebo Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Diagnostic
Official Title: Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
Study Start Date : November 2006
Primary Completion Date : July 2010
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I
Patients receive oral dutasteride once daily on days 1-14.
Drug: dutasteride
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo once daily on days 1-14.
Other: placebo
Given orally

Primary Outcome Measures :
  1. Efficacy of short-term dutasteride in improving prostate cancer detection
  2. Detection rate of prostate cancer
  3. Cost effectiveness of contrast-enhanced ultrasound

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy
  • Must not be clinically unstable, severely ill, or moribund


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398281

United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Cancer Institute (NCI)
Principal Investigator: Ethan J. Halpern, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ethan J. Halpern, Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
ClinicalTrials.gov Identifier: NCT00398281     History of Changes
Obsolete Identifiers: NCT00330057
Other Study ID Numbers: CDR0000513051
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs