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

NCT ID: NCT01964638

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Prostate Biopsy Targeted Biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Targeted Biopsy

Intervention Type PROCEDURE

Interventions

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Targeted Biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Samir Taneja, MD

Co-Director, Smilow Comprehensive Prostate Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samr S Taneja, MD

Role: PRINCIPAL_INVESTIGATOR

Co-Director, Smilow Comprehensive Prostate Cancer Center

Locations

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NYU Smilow Prostate Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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S12-01613

Identifier Type: -

Identifier Source: org_study_id