MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer

NCT ID: NCT01566045

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Detailed 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 with the addition of an endorectal-coil probe and a 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 12-14 core biopsies.

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Core Needle TRUS biopsy (Transrectal ultrasound)

Patient receiving core needle TRUS biopsy (Standard of care biopsy)

Group Type: ACTIVE_COMPARATOR

Core Needle TRUS Needle biopsy (Transrectal ultrasound)

Intervention Type: PROCEDURE

Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate

Core Needle MRI/US fusion guided biopsy

Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy

Group Type: EXPERIMENTAL

Core Needle MRI/US image fusion guided needle biopsy

Intervention Type: PROCEDURE

Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies

Interventions

Core Needle TRUS Needle biopsy (Transrectal ultrasound)

Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate

Intervention Type: PROCEDURE

Core Needle MRI/US image fusion guided needle biopsy

Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies

Intervention Type: PROCEDURE

Other Intervention Names

Core Needle biopsy; TRUS needle biopsy (Transrectal ultrasound); Core Needle biopsy; MRI/US image fusion guided needle biopsy

Eligibility Criteria

Inclusion Criteria

1. All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/NIH MR prostate imaging guidelines.

2. Age greater than 18 years.

3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.

4. 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.

5. Ability to tolerate conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia).

6. PSA > 2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association

7. Pre-biopsy prostate MRI as described above, showing targetable lesions within 2 months of biopsy

8. Able to tolerate a TRUS guided biopsy

Exclusion Criteria

1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.

2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.

3. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.

4. Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)

5. Patients with uncorrectable coagulopathies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Arthur Smith Institute for Urology

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

02072012

Identifier Type: -

Identifier Source: org_study_id