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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03366792
• Other study ID #: 14-01550
• Status: Terminated
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: February 26, 2021

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Artemis™ software system
Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Cancer Length	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)	2 Months
Secondary	Percentage of High-Grade Prostate Cancer Using Gleason Score	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)	2 Months