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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00242060
First received: October 18, 2005
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Elevated PSA
Prostate Cancer
 Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Utility of Functional and Morphologic MRI in the Detection of Prostate Cancer for Patients With Elevated PSA and Prior Negative Biopsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Study Start Date: November 2002
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242060

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Masoom Haider, MD University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242060     History of Changes
Other Study ID Numbers: 02-0065-C
Study First Received: October 18, 2005
Last Updated: July 14, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013