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

Prostate Cancer Clinical Trial

Official title:

Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964638
• Other study ID #: S12-01613
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: October 14, 2013
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Targeted Biopsy

Locations

Country	Name	City	State
United States	NYU Smilow Prostate Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One week after biopsy	No
Secondary	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.	One week after biopsy	No