View Clinical Trial (Medical Research Study)
Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
| City: |
|
Philadelphia |
| State: |
|
Pennsylvania |
| Zip Code: |
|
19107 |
| Conditions: |
|
Prostate Cancer |
| 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.
|
| Study Summary: |
|
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.
|
| 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
|
| NCT ID: |
|
NCT00398281 |
| Primary Contact: |
|
Principal Investigator
Ethan J. Halpern, MD
Kimmel Cancer Center (KCC)
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Philadelphia, Pennsylvania 19107
United States
Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer
Phone: 215-955-6084
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|