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

NCT01964638 | Completed DMC

• 1 other identifier: S12-01613
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Prostate Biopsy; Targeted Biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of Rate of cancer diagnosis using targeted biopsy

  One week after biopsy

Study Arms (1)

Targeted Biopsy

OTHER

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.

Procedure: Targeted Biopsy

Interventions

Targeted Biopsy PROCEDURE

Targeted Biopsy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Smilow Prostate Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Samr S Taneja, MD

  Co-Director, Smilow Comprehensive Prostate Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Smilow Comprehensive Prostate Cancer Center

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 17, 2013
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 17, 2013

Record last verified: 2013-10

Locations

US (1)