Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe

• Registration Number: NCT01780701
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

A prostate cancer diagnosis starts a list of events that often leads to fast-moving treatment, thought by many to result in vast over-treatment of this disease. So, discovery of different diagnostic methods that allow clinicians to identify slow-growing from potentially fast-growing disease prior to or at the time of prostate biopsy could result in early and suitable treatment for men at greatest risk, while greatly decreasing the number of biopsies, surgical procedures, hormonal and chemotherapeutic treatments, cost, and patient worry, for those with more slow-growing disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Primary Completion: 2016-01
• Status Verified: 2016-11
• Study Completion: 2017-03
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Prostate cancer diagnosis prior to treatment
• Age 21 years or older
• Signed informed subject consent
• Prostatectomy as planned prostate cancer treatment

Exclusion Criteria

• Men who do not choose prostatectomy
• Men who have undergone any neoadjuvant therapy
• Men who have cardiac pacemakers or other implanted electronic devices
• Men who have any surgically implanted metal
• Men who have had any surgical procedure that precludes placement of endorectal probe
• Indication of dementia or memory issues listed on problem list
• Men who indicate exposure to ocular metal fragments; confirmed by positive ocular x-ray
• Men who are taking newly-prescribed (within 6 months of enrollment) lipid control medications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low risk prostate cancer patients	Magnetic Resonance Spectroscopy Imaging with rectal probe	Men who have been recently diagnosed with low risk prostate cancer (Gleason score 7 \[3+4\] and below) and who choose prostate removal for their cancer treatment will undergo Magnetic Resonance Spectroscopy Imaging (MRSI) with rectal probe at the Oregon Health \& Science University's Advanced Imaging Research Center.
High risk prostate cancer patients	Magnetic Resonance Spectroscopy Imaging with rectal probe	Men who have been recently diagnosed with high risk prostate cancer (Gleason score 7 and above) and who choose prostate removal for their cancer treatment will undergo Magnetic Resonance Spectroscopy Imaging (MRSI) with rectal probe at the Oregon Health \& Science University's Advanced Imaging Research Center.

Primary Outcome Measures

Name	Time	Method
Number of participants with increased intraprostatic lipid concentration	Up to 3 years	Determine the correlation between the amount of intraprostatic lipid using 1H (proton) magnetic resonance spectroscopic imaging (MRSI) with an endorectal coil obtained prior to prostatectomy with fatty acid synthase protein expression measured in benign and cancer tissue from prostatectomy samples.

Secondary Outcome Measures

Name	Time	Method
Number of participants with increased tumor aggressiveness	Up to 3 years	Identify the association between fatty acid synthase protein expression in prostatectomy samples, intraprostatic lipid as measured by 1H MRSI, and prostate tumor aggressiveness.

Trial Locations

Locations (2)

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States

Oregon Health & Science University Advanced Imaging Research Center; 🇺🇸 Portland, Oregon, United States