Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Official title:

Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237612
• Other study ID #: 4P-08-4
• Secondary ID: NCI-2014-01848HS
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: September 9, 2014
• Start date: January 2009
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.

Description:

PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.

OUTLINE:

Patients undergo diffusion-weighted MRI of the pelvis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:

• Gleason >= 7

• > 50% biopsy cores +

• Prostate-specific antigen (PSA) >= 10

• Interested in undergoing a radical prostatectomy as definitive management for prostate cancer

• No clinical or radiographic evidence for distant metastatic disease

• In subjects with PSA < 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA > 20, a bone scan must document lack of concern for bone involvement

Exclusion Criteria:

• Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor

• History of claustrophobia

• Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria

• Unable to give written informed consent

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

Procedure:
• diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI	Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.	Baseline	No