MR/TRUS Fusion Guided Prostate Biopsy

Mount Sinai Health System

Status: Unknown

Conditions: Elevated Prostate Specific Antigen; Prostate Disease; Positive Digital Rectal Exam; Family History of Prostate Cancer

Treatments: Device: MR/TRUS Fusion Guided Prostate Biopsy; Procedure: prostate biopsy; Procedure: MR US Fusion Guided Prostate Biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04026763

GCO 15-0768

Details and patient eligibility

About

This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.

Full description

The efficacy of targeting lesions for surgery may be limited by the visibility of a target during the procedure. The successful outcome of surgical intervention depends upon accurate device placement, which may be very challenging in certain settings, such as when a kidney tumor only is visible for a brief moment during the transient arterial phase of a contrast injection, and soon disappearing on dynamic imaging.

Historically, prostate cancer was diagnosed by digitally guided trans-rectal prostate biopsies. With PSA (Prostate Specific Antigen) screening and improvements in ultrasonography, trans-rectal ultrasound (TRUS) guided prostate biopsy have become the standard of care to screen and diagnose localized prostate cancer. Standard US 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients.

Prostate MR imaging at 3 Tesla magnet dramatically improves diagnostic utility dramatically but biopsies are difficult, time-consuming, and require specialized equipment, which increases the cost significantly.

To meet this challenge TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.

This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. Each patient will act as their own control.

Enrollment: 520 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines.
• Age greater than 18 years.
• No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
• The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
• Ability to tolerate sedation and or general anesthesia if required.
• PSA >2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
• Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
• Able to tolerate a ultrasound guided biopsy

Exclusion criteria

• Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
• Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
• Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
• Patients with uncorrectable coagulopathies.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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520 participants in 1 patient group

Males with Prostate Cancer

Experimental group

Description:

Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy.

Treatment:

Procedure: MR US Fusion Guided Prostate Biopsy

Procedure: prostate biopsy

Device: MR/TRUS Fusion Guided Prostate Biopsy