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CompletedNCT00398281Updated Jan 10, 2014

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

A Phase 3 interventional study of dutasteride and placebo in Prostate Cancer, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 450 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Masking
Double
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    Arm I

    Patients receive oral dutasteride once daily on days 1-14.

    Drug: dutasteride

  • Placebo comparator
    Arm II

    Patients receive oral placebo once daily on days 1-14.

    Other: placebo

Interventions

  • Drugdutasteride

    Given orally

  • Otherplacebo

    Given orally

06

What researchers measure

Primary outcomes

  1. Efficacy of short-term dutasteride in improving prostate cancer detection

  2. Detection rate of prostate cancer

  3. Cost effectiveness of contrast-enhanced ultrasound

07

Study locations

1 site
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    Philadelphia, Pennsylvania 19107-5541, United States
08

References and documents

Publications

  • Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19. PubMed 22998915 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00398281
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
First posted
Nov 10, 2006
Start date
Nov 2006
Primary completion
Jul 2010
Completion
Sep 2012
Last update
Jan 10, 2014

Study contacts

Ethan J. Halpern, MD
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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