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

Study Overview
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Brief Summary
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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.

Official Title
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Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk prostate cancer patients<br>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. | Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe<br> <br> * Other names: MRI;|
| Low risk prostate cancer patients<br>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. | Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe<br> <br> * Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with increased intraprostatic lipid concentration | 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. | Up to 3 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer aggressiveness, magnetic resonance imaging, fatty acid synthase