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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Targeted Biopsy

• Registration Number: NCT01964638
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-14
• Last Update Submitted: 2013-10-14
• Study First Posted: 2013-10-17
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 126

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted Biopsy	Targeted Biopsy	Men being evaluated for prostate cancer based upon standard of care clinical parameters (e.g. elevated PSA levels, abnormal DRE, mpMRI) will be considered for enrollment. Men who have undergone prostate mpMRI that has revealed an area(s) of suspicion for prostate cancer are eligible for enrollment. All men enrolled in the study undergo fusion targeted biopsy, visual estimation biopsy, and systematic biopsy. As a result the study includes a single arm with direct comparison of biopsy techniques.

Primary Outcome Measures

Name	Time	Method
Evaluation of rates of prostate cancer diagnosis	One week after biopsy	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Rate of cancer diagnosis using targeted biopsy	One week after 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.

Trial Locations

Locations (1)

NYU Smilow Prostate Cancer Center; 🇺🇸 New York, New York, United States