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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014