Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

NCT02237612 | Completed

• 5 other identifiers: 4P-08-4NCI-2014-01848HS-08-00413-CR004HS-08-00413P30CA014089
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Prostate; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (diffusion-weighted MRI)

EXPERIMENTAL

Patients undergo diffusion-weighted MRI of the pelvis.

Procedure: diffusion-weighted magnetic resonance imaging; Other: laboratory biomarker analysis

Interventions

diffusion-weighted magnetic resonance imaging PROCEDURE

Undergo diffusion-weighted MRI

Also known as: diffusion-weighted MRI

Diagnostic (diffusion-weighted MRI)

laboratory biomarker analysis OTHER

Correlative studies

Diagnostic (diffusion-weighted MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tanya Dorff

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 11, 2014
• Study Start: January 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

US (1)