MR/TRUS Fusion Guided Prostate Biopsy

Prostate Disease Clinical Trial

Official title:

MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026763
• Other study ID #: GCO 15-0768
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Ardeshir Rastinehad, DO
• Phone: 212-241-4812
• Email: art.rastinehad[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elevated Prostate Specific Antigen
• Family History of Prostate Cancer
• Positive Digital Rectal Exam
• Prostate Disease
• Prostatic Diseases
• Prostatic Neoplasms

Intervention

Procedure:
• prostate biopsy
standard of care
• MR US Fusion Guided Prostate Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy

Device:
• MR/TRUS Fusion Guided Prostate Biopsy
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Prostate Cancer	Incidence of diagnosing subjects with prostate cancer with MR visible lesions	Day 0 - day of procedure
Secondary	Incidence of adverse events	the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy	1 month
Secondary	Pirads score	The Prostate Imaging Reporting and Data System (PIRADS) score classifies MRI lesions on a scale from 1 to 5, which reflects their level of suspicion from least to most. Higher score indicates more suspicion.	1 month
Secondary	Gleason score	The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Sum of the gleason grade of the most predominant tumor pattern and a second gleason grade of the second most predominant pattern. Full score from 2 to 10, with higher score indicating more clinically significance.	1 month