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

NCT ID: NCT01780701

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Magnetic Resonance Spectroscopy Imaging with rectal probe

Intervention Type PROCEDURE

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.

Magnetic Resonance Spectroscopy Imaging with rectal probe

Intervention Type PROCEDURE

Interventions

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Magnetic Resonance Spectroscopy Imaging with rectal probe

Intervention Type PROCEDURE

Other Intervention Names

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Magnetic Resonance Spectroscopy Imaging MRSI Magnetic Resonance Imaging MRI

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Portland VA Medical Center

FED

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Jackie Shannon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jackilen Shannon, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Jonathan Q Purnell, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Portland VA Medical Center

Portland, Oregon, United States

Site Status

Oregon Health & Science University Advanced Imaging Research Center

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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W81XWH-12-1-0168

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2978

Identifier Type: OTHER

Identifier Source: secondary_id

8458

Identifier Type: OTHER

Identifier Source: secondary_id

Log #A-17208

Identifier Type: OTHER

Identifier Source: secondary_id

PC110361

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00008458

Identifier Type: -

Identifier Source: org_study_id

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