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Completed

NCT Number: NCT01780701

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer, Hereditary, 7 Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Oregon Health & Science University Advanced Imaging Research Center, Portland, Oregon, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Spectroscopy Imaging with rectal probe

Procedure

Other names: Magnetic Resonance Spectroscopy Imaging, MRSI, Magnetic Resonance Imaging, MRI

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Oregon Health and Science University
  • Portland VA Medical Center
  • United States Department of Defense

Registry information

Official study title

Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

Acronym: MRSI+RRP

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 31, 2013
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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