Status:
COMPLETED
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief 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 ye...
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00398281
Start Date
November 1 2006
End Date
September 1 2012
Last Update
January 10 2014
Active Locations (1)
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1
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541