Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00398281
First received: November 9, 2006
Last updated: January 9, 2014
Last verified: June 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: dutasteride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy of short-term dutasteride in improving prostate cancer detection [ Designated as safety issue: No ]
  • Detection rate of prostate cancer [ Designated as safety issue: No ]
  • Cost effectiveness of contrast-enhanced ultrasound [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: November 2006
Study Completion Date: September 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398281

Locations
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Sponsors and Collaborators
Kimmel Cancer Center (KCC)
Investigators
Principal Investigator: Ethan J. Halpern, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional 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, TJUH-06F-145
Study First Received: November 9, 2006
Last Updated: January 9, 2014
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014