Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer

NCT ID: NCT01764347

Last Updated: 2014-01-28

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-09-30

Brief Summary

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This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.

OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Conditions

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Prostate Cancer

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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Diagnostic (MRI-TRUS fusion image-guided biopsy)

Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Group Type EXPERIMENTAL

therapeutic conventional surgery

Intervention Type PROCEDURE

Undergo robotic radical prostatectomy

ultrasound-guided prostate biopsy

Intervention Type PROCEDURE

Undergo MRI-TRUS fusion image-guided prostate biopsy

magnetic resonance imaging

Intervention Type PROCEDURE

Undergo MRI-TRUS fusion image-guided prostate biopsy

Interventions

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therapeutic conventional surgery

Undergo robotic radical prostatectomy

Intervention Type PROCEDURE

ultrasound-guided prostate biopsy

Undergo MRI-TRUS fusion image-guided prostate biopsy

Intervention Type PROCEDURE

magnetic resonance imaging

Undergo MRI-TRUS fusion image-guided prostate biopsy

Intervention Type PROCEDURE

Other Intervention Names

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MRI NMR imaging NMRI nuclear magnetic resonance imaging

Eligibility Criteria

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Inclusion Criteria

* Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) \>= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
* Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
* Subjects must have decided to have their prostate surgically removed

Exclusion Criteria

* Patients who do not give informed consent
* Patients with extracapsular extension of their prostate cancer
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osamu Ukimura

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-03037

Identifier Type: REGISTRY

Identifier Source: secondary_id

4P-10-6

Identifier Type: -

Identifier Source: org_study_id

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