Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01780701
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
United States Department of Defense
Portland VA Medical Center
Oregon Health and Science University
Information provided by (Responsible Party):
Jackie Shannon, OHSU Knight Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Prostate Cancer Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer
Study Start Date : January 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • Magnetic Resonance Spectroscopy Imaging
  • MRSI
  • Magnetic Resonance Imaging
  • MRI
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:
  • Magnetic Resonance Spectroscopy Imaging
  • MRSI
  • Magnetic Resonance Imaging
  • MRI


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with increased intraprostatic lipid concentration [ Time Frame: 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 :
  1. Number of participants with increased tumor aggressiveness [ Time Frame: 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.


Other Outcome Measures:
  1. Number of participants with accumulation of lipid intermediates and proteins [ Time Frame: Up to 3 years ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood, Urine, Prostatic fluid and Prostatectomy tissue

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all men newly-diagnosed with prostate cancer at the Portland VA and OHSU Urology clinics
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780701


Locations
Layout table for location information
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97207
Oregon Health & Science University Advanced Imaging Research Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
United States Department of Defense
Portland VA Medical Center
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Jackilen Shannon, PhD Oregon Health and Science University
Principal Investigator: Jonathan Q Purnell, MD Oregon Health and Science University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01780701    
Other Study ID Numbers: IRB00008458
W81XWH-12-1-0168 ( Other Grant/Funding Number: Dept of Defense )
2978 ( Other Identifier: Portland VA Medical Center IRB )
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 )
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: November 2016
Keywords provided by Jackie Shannon, OHSU Knight Cancer Institute:
prostate cancer aggressiveness
magnetic resonance imaging
fatty acid synthase
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases