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Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
David S Finley, MD, Kaiser Permanente

Brief Summary:
Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging (mpMRI) is an imaging test that may improve prostate cancer detection rates in this population of men. In this prospective randomized trial multicenter trial the investigators will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared with the addition of either a computer targeted system (UroNav - InVivo corp) to sample suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these areas and systematic biopsy alone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: MRI UroNav fusion biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


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
Procedure: MRI UroNav fusion biopsy
Other Name: UroNav (InVivo corp)




Primary Outcome Measures :
  1. Prostate cancer detection rate [ Time Frame: 1 week after biopsy ]
    Prostate cancer detection rate between MRI guided free hand biopsy and UroNav targeted biopsy


Secondary Outcome Measures :
  1. Clinically significant prostate cancer detection rate [ Time Frame: 1 week after biopsy ]
    Detection rate between techiques of Gleason 4 or higher prostate cancer


Other Outcome Measures:
  1. Tumor volume [ Time Frame: 1 week after biopsy ]
    % core involvement of cancer between techniques



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138760


Contacts
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Contact: David S Finley, MD 3237835500 David.S.Finley@kp.org

Locations
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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         
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: David S Finley, MD Kaiser Permanente
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Responsible Party: David S Finley, MD, Director of Robotic Surgery, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02138760    
Other Study ID Numbers: KP-MRI-2014
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014
Keywords provided by David S Finley, MD, Kaiser Permanente:
prostate cancer
prostate biopsy
magnetic resonance imaging guidance
detection rates
performance
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases