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

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

Sponsors

Lead sponsor: Kaiser Permanente

Source 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.

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.

Overall Status Unknown status
Start Date August 2014
Completion Date December 2015
Primary Completion Date August 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prostate cancer detection rate 1 week after biopsy
Secondary Outcome
Measure Time Frame
Clinically significant prostate cancer detection rate 1 week after biopsy
Enrollment 400
Condition
Intervention

Intervention type: Procedure

Intervention name: MRI UroNav fusion biopsy

Arm group label: UroNav fusion biopsy

Other name: UroNav (InVivo corp)

Eligibility

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)

Gender: Male

Minimum age: 30 Years

Maximum age: 79 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
David S Finley, MD Principal Investigator Kaiser Permanente
Overall Contact

Last name: David S Finley, MD

Phone: 3237835500

Email: [email protected]

Location
facility
Kaiser Permanente Los Angeles (Sunset) | Los Angeles, California, 90027, United States
Kaiser Permanente Riverside | Riverside, California, 92505, United States Stephen G Williams, MD [email protected] Stephen G Williams, MD Sub-Investigator
Location Countries

United States

Verification Date

May 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Kaiser Permanente

Investigator full name: David S Finley, MD

Investigator title: Director of Robotic Surgery

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: MRI guided cognitive fusion biopsy

Arm group type: No Intervention

Description: Men in this arm will undergo MRI followed by systematic biopsy and then additional cognitive (freehand) biopsies of MRI suspicious targets

Arm group label: UroNav fusion biopsy

Arm group type: Experimental

Description: Men in this arm will undergo MRI followed by systematic biopsy and then additional UroNav fusion biopsy of MRI suspicious targets

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov