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


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

One month after last patient enrolled is taken off study

Safety Issue:

No

Principal Investigator

Osamu Ukimura

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

4P-10-6

NCT ID:

NCT01764347

Start Date:

November 2010

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

USC Norris Comprehensive Cancer CenterLos Angeles, California  90089