Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Device: Artemis™ software system

• Registration Number: NCT03366792
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.

Detailed Description

Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.

Study Timeline

• Study Start: 2017-10-17
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Status Verified: 2022-02
• Results First Submitted: 2022-02-24
• Results First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Results First Posted: 2022-03-23
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

• No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score >3/5)

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Exclusion Criteria

• Prior pelvic radiotherapy
• Evidence of urinary tract infection or significant urinary retention
• Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
• No evidence of suspicious lesions on mpMRI
• Irreversible coagulopathy
• Contraindication to sedation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI Targeted Biopsy	Artemis™ software system	-

Primary Outcome Measures

Name	Time	Method
Core Cancer Length	2 Months	Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)

Secondary Outcome Measures

Name	Time	Method
Percentage of High-Grade Prostate Cancer Using Gleason Score	2 Months	High-grade prostate cancer is defined as a Gleason score \> 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.; Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States