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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
United States Department of Defense
Portland VA Medical Center
Oregon Health and Science University
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01780701
First received: January 7, 2013
Last updated: April 8, 2016
Last verified: April 2016
History of Changes
  Purpose
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 Intervention
Prostate Cancer
 Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Number of participants with increased intraprostatic lipid concentration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Number of participants with increased tumor aggressiveness [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Number of participants with accumulation of lipid intermediates and proteins [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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

Enrollment: 66
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780701

Locations
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
Principal Investigator: Jackilen Shannon, PhD Oregon Health and Science University
Principal Investigator: Jonathan Q Purnell, MD Oregon Health and Science University
  More Information

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01780701     History of Changes
Other Study ID Numbers: IRB00008458  W81XWH-12-1-0168  2978  8458  Log #A-17208  PC110361 
Study First Received: January 7, 2013
Last Updated: April 8, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
prostate cancer aggressiveness
magnetic resonance imaging
fatty acid synthase

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 29, 2016