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NCT Number: NCT02237612

Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

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.

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Key information

Conditions

Adenocarcinoma of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage IIA Prostate Cancer Stage IIB Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diffusion-weighted magnetic resonance imaging

Procedure

Undergo diffusion-weighted MRI

Other names: diffusion-weighted MRI

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2014
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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