Back to results

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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

therapeutic conventional surgery

ultrasound-guided prostate biopsy

magnetic resonance imaging

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (MRI-TRUS fusion image-guided biopsy)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of times the first biopsy needle is placed within 3.0 mm of the center lesion

A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).

Number of times the second biopsy needle is placed within 3.0 mm of the center lesion

Secondary Outcome Measures

Average distance of the first needle to the center of the lesion

A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated.

Average distance of the second needle from the first needle minus 2.0 mm

A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Average distance of the third needle from the first needle minus 2.0 mm

A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Full Information

NCT ID

NCT01764347

First Posted

December 21, 2012

Last Updated

January 27, 2014

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01764347

Brief Title

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

Official Title

Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (MRI-TRUS fusion image-guided biopsy)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Undergo robotic radical prostatectomy

Intervention Type

Procedure

Intervention Name(s)

ultrasound-guided prostate biopsy

Intervention Description

Undergo MRI-TRUS fusion image-guided prostate biopsy

Intervention Type

Procedure

Intervention Name(s)

magnetic resonance imaging

Other Intervention Name(s)

MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Intervention Description

Undergo MRI-TRUS fusion image-guided prostate biopsy

Primary Outcome Measure Information:

Title

Number of times the first biopsy needle is placed within 3.0 mm of the center lesion

Description

Time Frame

One month after last patient enrolled is taken off study

Title

Number of times the second biopsy needle is placed within 3.0 mm of the center lesion

Description

Time Frame

One month after last patient enrolled is take off study

Secondary Outcome Measure Information:

Title

Average distance of the first needle to the center of the lesion

Description

Time Frame

One month after last patient enrolled is taken off study

Title

Average distance of the second needle from the first needle minus 2.0 mm

Description

A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Time Frame

One month after last patient enrolled is taken off study

Title

Average distance of the third needle from the first needle minus 2.0 mm

Description

A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Time Frame

One month after last patient enrolled is taken off study

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osamu Ukimura

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

USC Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs