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

Prostate Cancer Clinical Trial

— MRSI+RRP  

Official title:

Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780701
• Other study ID #: IRB00008458
• Secondary ID: W81XWH-12-1-0168
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: April 25, 2017
• Start date: January 2013
• Est. completion date: March 2017

Study information

• Verified date: November 2016
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Magnetic Resonance Spectroscopy Imaging with rectal probe

Locations

Country	Name	City	State
United States	Oregon Health & Science University Advanced Imaging Research Center	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University, Portland VA Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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