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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00242060
Other study ID # 02-0065-C
Secondary ID
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


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, 

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