Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02237612

Enrollment

Registered

2014-09-11

Start date

2009-01-31

Completion date

2013-03-31

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

PROCEDUREdiffusion-weighted magnetic resonance imaging

Undergo diffusion-weighted MRI

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI	Baseline	Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026