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NCT Number: NCT00398281

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dutasteride

Drug

Given orally

Placebo

Other

Given orally

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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Nov 10, 2006
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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