Functional and Morphologic MRI in the Detection of Prostate Cancer in Patients With Prior Negative Biopsy

Not Applicable

Completed

• Conditions: Elevated PSA; Prostate Cancer

• Registration Number: NCT00242060
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Detailed Description

Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Primary Completion: 2008-04
• Study Completion: 2008-11
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• prior ultrasound biopsy of prostate showing no cancer or only single microfocus of cancer

Read More

Exclusion Criteria

• contraindication to contrast enhanced endorectal coil MRI

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada