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

• ClinicalTrials.gov Identifier: NCT02138760
• Recruitment Status: Unknown
• First Posted: May 15, 2014
• Last Update Posted: May 15, 2014
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): David S Finley, MD, Kaiser Permanente

Study Description

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.

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: David S Finley, MD; Kaiser Permanente

More Information

• 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
• 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:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases