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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 has been completed.
Sponsor:
OHSU Knight Cancer Institute
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
ClinicalTrials.gov Identifier:
NCT01780701
First received: January 7, 2013
Last updated: April 25, 2017
Last verified: November 2016
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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:
Further study details as provided by Jackie Shannon, OHSU Knight Cancer Institute:
Primary Outcome Measures:
- 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:
- 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:
- 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
| Enrollment: | 66 |
| Study Start Date: | January 2013 |
| Study Completion Date: | March 2017 |
| 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:
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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:
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Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| 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
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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
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: | Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01780701 History of Changes |
| 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 ) |
| Study First Received: | January 7, 2013 |
| Last Updated: | April 25, 2017 |
Keywords provided by Jackie Shannon, 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 June 23, 2017