Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment magnetic resonance spectroscopy imaging with rectal probe
Sponsor OHSU Knight Cancer Institute
Collaborator United States Department of Defense
Start date January 2013
End date January 2016
Trial size 66 participants
Trial identifier NCT01780701, 2978, 8458, IRB00008458, Log #A-17208, PC110361, W81XWH-12-1-0168

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
Arm
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.
magnetic resonance spectroscopy imaging with rectal probe Magnetic Resonance Spectroscopy Imaging
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.
magnetic resonance spectroscopy imaging with rectal probe Magnetic Resonance Spectroscopy Imaging

Primary Outcomes

Measure
Number of participants with increased intraprostatic lipid concentration
time frame: Up to 3 years

Secondary Outcomes

Measure
Number of participants with increased tumor aggressiveness
time frame: Up to 3 years

Eligibility Criteria

Male participants at least 21 years old.

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

Additional Information

Official title Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer
Principal investigator Jackilen Shannon, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by OHSU Knight Cancer Institute.