Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

University of Southern California

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02237612

HS-08-00413

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2014-01848 (Registry Identifier)

HS-08-00413-CR004

4P-08-4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Diagnostic (diffusion-weighted MRI)

Experimental group

Description:

Patients undergo diffusion-weighted MRI of the pelvis.

Treatment:

Procedure: diffusion-weighted magnetic resonance imaging

Other: laboratory biomarker analysis