Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 278 for:    prostate cancer AND localized | ( Map: United States )

Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02237612
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Stage IIA Prostate Cancer Stage IIB Prostate Cancer Procedure: diffusion-weighted magnetic resonance imaging Other: laboratory biomarker analysis Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study
Study Start Date : January 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (diffusion-weighted MRI)
Patients undergo diffusion-weighted MRI of the pelvis.
Procedure: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: diffusion-weighted MRI

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI [ Time Frame: Baseline ]
    Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237612


Locations
Layout table for location information
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Tanya Dorff University of Southern California

Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02237612     History of Changes
Other Study ID Numbers: 4P-08-4
NCI-2014-01848 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HS-08-00413-CR004
HS-08-00413
4P-08-4 ( Other Identifier: USC Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Genital Diseases, Male
Carcinoma