- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138760
Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prostate cancer (PC) is the second most common cancer in men in the United States, affecting approximately 250,000 men per year. With the advent of the prostate specific antigen (PSA) blood test, PC has undergone downward stage migration resulting in earlier cancer detection. In the pre-PSA era, tumors presented with advanced stage which were often visible on transrectal ultrasound. In the modern era, tumors more often are microscopic and not apparent on ultrasound imaging which creates a diagnostic challenge in which biopsy is essentially blind. As a result, many tumors are missed resulting in subsequent biopsies, tumor progression, and decreased cancer-specific survival due to delayed diagnosis.
Multiparametric magnetic resonance imaging (mpMRI) of the prostate has now become the preferred imaging modality to visualize prostate tumors radiographically. mpMRI has become increasing utilized for targeting tumor suspicious areas in the prostate in men with prior negative conventional systematic biopsy. Numerous studies have shown MRI targeted biopsy results in detection of cancer in this subset of men in approximately 30-60% of patients (refs). In addition, MRI detects a higher number of aggressive prostate cancers which would require treatment.
Several methods of incorporating MRI into biopsy targeting have been tested: 1) in gantry/in bore MRI biopsy 2) Robotic biopsy (Artemis) 3) UroNav ultrasound-MR fusion biopsy. The first two techniques are cumbersome and difficult to use in clinical practice. The latter technology is the most widely utilized, user and patient friendly technique. UroNav utilizes a work-station which imports the MRI and then co-registers (fuses) it with real time ultrasound; the ultrasound transducer communicates with an electromagnetic received above the patient to allow the work-station/computer to target suspicious MRI lesions to guide the users needle to the appropriate 3-dimensional location. Data has shown this to be more effective than either systematic biopsy or free-MRI guided biopsy.
The goal of the present study is to compare head-to-head systematic biopsy + freehand MRI targeted biopsy vs systematic biopsy + UroNav targeted in men with elevated PSA and prior negative systematic biopsy.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90027
- Kaiser Permanente Los Angeles (Sunset)
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Riverside, California, United States, 92505
- Kaiser Permanente Riverside
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PSA > 2.5 ng/ml (ages 30-50) or PSA > 4.0 ages (50-79)
- Patients with prior negative prostate biopsy
- Written informed consent
- Age > 30
Exclusion Criteria:
- Prior diagnosis of prostate cancer
- Age> 79
- No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies, anatomical contraindications)
- Active urinary tract infection or indwelling catheter
- Prior pelvic irradiation
- Prior androgen deprivation hormonal therapy
- Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8 weeks prior to mpMRI.
- Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with MRI)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: MRI guided cognitive fusion biopsy
Men in this arm will undergo MRI followed by systematic biopsy and then additional cognitive (freehand) biopsies of MRI suspicious targets
|
|
Experimental: UroNav fusion biopsy
Men in this arm will undergo MRI followed by systematic biopsy and then additional UroNav fusion biopsy of MRI suspicious targets
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate cancer detection rate
Time Frame: 1 week after biopsy
|
Prostate cancer detection rate between MRI guided free hand biopsy and UroNav targeted biopsy
|
1 week after biopsy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically significant prostate cancer detection rate
Time Frame: 1 week after biopsy
|
Detection rate between techiques of Gleason 4 or higher prostate cancer
|
1 week after biopsy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor volume
Time Frame: 1 week after biopsy
|
% core involvement of cancer between techniques
|
1 week after biopsy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David S Finley, MD, Kaiser Permanente
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KP-MRI-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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