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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

MRI

About this trial

This is an interventional diagnostic trial for Elevated PSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Health Network, Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00242060

First Posted

October 18, 2005

Last Updated

July 14, 2010

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT00242060

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elevated PSA, Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

MRI

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masoom Haider, MD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network, Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Elevated PSA, Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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