Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
18 Years
80 Years
Male
Prostate Cancer
Trial Information
Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Diagnostic
Outcome Measure:
Efficacy of short-term dutasteride in improving prostate cancer detection
Safety Issue:
No
Principal Investigator
Ethan J. Halpern, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kimmel Cancer Center (KCC)
Authority:
Unspecified
Study ID:
CDR0000513051
NCT ID:
NCT00398281
Start Date:
November 2006
Completion Date:
Related Keywords:
- Prostate Cancer
- prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
