Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer (MRSI+RRP)

Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97207
      • Portland VA Medical Center
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University Advanced Imaging Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

all men newly-diagnosed with prostate cancer at the Portland VA and OHSU Urology clinics

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High risk prostate cancer patients; 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; Other Names: MRI; Magnetic Resonance Imaging; MRSI; Magnetic Resonance Spectroscopy Imaging
Low risk prostate cancer patients; 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; Other Names: MRI; Magnetic Resonance Imaging; MRSI; Magnetic Resonance Spectroscopy Imaging

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with accumulation of lipid intermediates and proteins	To quantify the association between key metabolic intermediates involved in lipid metabolism, mitochondrial function, inflammation, and apoptosis in prostatectomy samples and fatty acid synthase protein expression, intraprostatic lipid and tumor aggressiveness.	Up to 3 years

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: United States Department of Defense; Oregon Health and Science University; Portland VA Medical Center
• Investigators: Principal Investigator: Jonathan Q Purnell, MD, Oregon Health and Science University; Principal Investigator: Jackilen Shannon, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; fatty acid synthase; prostate cancer aggressiveness
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRB00008458; 2978 (Other Identifier: Portland VA Medical Center IRB); W81XWH-12-1-0168 (Other Grant/Funding Number: Dept of Defense); 8458 (Other Identifier: Oregon Health & Science University IRB); Log #A-17208 (Other Identifier: Dept of Defense Human Research Protection Office); PC110361 (Other Identifier: Dept of Defense)