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

Prostate Cancer Clinical Trial

Official title:

The Utility of Functional and Morphologic MRI in the Detection of Prostate Cancer for Patients With Elevated PSA and Prior Negative Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242060
• Other study ID #: 02-0065-C
• Status: Completed
• Phase: N/A
• First received: October 18, 2005
• Last updated: July 14, 2010
• Start date: November 2002
• Est. completion date: November 2008

Study information

• Verified date: July 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• contraindication to contrast enhanced endorectal coil MRI

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Elevated PSA
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• MRI

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada,