Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy
|ClinicalTrials.gov Identifier: NCT02138760|
Recruitment Status : Unknown
Verified May 2014 by David S Finley, MD, Kaiser Permanente.
Recruitment status was: Not yet recruiting
First Posted : May 15, 2014
Last Update Posted : May 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: MRI UroNav fusion biopsy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
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
Procedure: MRI UroNav fusion biopsy
Other Name: UroNav (InVivo corp)
- Prostate cancer detection rate [ Time Frame: 1 week after biopsy ]Prostate cancer detection rate between MRI guided free hand biopsy and UroNav targeted biopsy
- Clinically significant prostate cancer detection rate [ Time Frame: 1 week after biopsy ]Detection rate between techiques of Gleason 4 or higher prostate cancer
- Tumor volume [ Time Frame: 1 week after biopsy ]% core involvement of cancer between techniques
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138760
|Contact: David S Finley, MD||3237835500||David.S.Finley@kp.org|
|United States, California|
|Kaiser Permanente Los Angeles (Sunset)|
|Los Angeles, California, United States, 90027|
|Kaiser Permanente Riverside|
|Riverside, California, United States, 92505|
|Contact: Stephen G Williams, MD Stephen.G.Williams@kp.org|
|Sub-Investigator: Stephen G Williams, MD|
|Principal Investigator:||David S Finley, MD||Kaiser Permanente|