Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.

N/ACompletedNCT01964638

NYU Langone Health126 enrolled

Overview

This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

126

Conditions

Prostate Cancer

Interventions

Targeted BiopsyPROCEDURE

Eligibility

Sex: MALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * No previous diagnosis of adenocarcinoma of the prostate * No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations) * Active urinary tract infection Exclusion Criteria: * Prior pelvic radiotherapy * Prior androgen deprivation therapy * Evidence urinary tract infection or significant urinary retention * Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI. * Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)

Locations (1)

NYU Smilow Prostate Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Evaluation of rates of prostate cancer diagnosis

The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.

Time frame: One week after biopsy

Secondary Outcomes

Evaluation of Rate of cancer diagnosis using targeted biopsy

The secondary endpoint of the study is the evaluation of the rate of cancer diagnosis using targeted biopsy (software or cognitive targeting) as compared to standard of care prostate biopsy.

Time frame: One week after biopsy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.