NCT04599218

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,586 (estimated)
• Sponsor: Ardeshir Rastinehad · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy.

Detailed description

The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement. Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA. Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion. 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. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.

Conditions

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

Interventions

Type	Name	Description
OTHER	Prostate Biopsy	Standard of care
OTHER	MR US Fusion Guided Prostate Biopsy	Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) 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.

Timeline

• Start date: 2020-08-21
• Primary completion: 2025-10-15
• Completion: 2026-01-15
• First posted: 2020-10-22
• Last updated: 2024-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study