MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer

Summary

This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy.

Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.

Conditions

• Prostate Cancer

Interventions

DEVICE

Artemia

Before prostate biopsy, all patients be preceded by mpMRI.MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.

Sponsors & Collaborators

• Bumjin Lim

  collaborator UNKNOWN

• Dalsan Yoo

  collaborator UNKNOWN

• Hyung Keun Park

  collaborator UNKNOWN

• Jun Hyuk Hong

  collaborator UNKNOWN

• Hanjong Ahn

  collaborator UNKNOWN

• Choung-Soo Kim

  collaborator UNKNOWN

• Kye Jin Park

  collaborator UNKNOWN

• Mi-Hyun Kim

  collaborator UNKNOWN

• Jeong Kon Kim

  collaborator UNKNOWN

• Asan Medical Center

  lead OTHER

Principal Investigators

• In Gab Jeong, MD, PhD · Asan Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-23

Primary Completion

2021-04-01

Completion

2023-04-01

FDA Device

Yes

Countries

• South Korea

Study Locations