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

Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01780701

Acronym

MRSI+RRP

Enrollment

Registered

2013-01-31

Start date

2013-01-31

Completion date

2017-03-31

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer aggressiveness, magnetic resonance imaging, fatty acid synthase

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.

Interventions

PROCEDUREMagnetic Resonance Spectroscopy Imaging with rectal probe

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with increased intraprostatic lipid concentration	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

Measure	Time frame	Description
Number of participants with increased tumor aggressiveness	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

Measure	Time frame	Description
Number of participants with accumulation of lipid intermediates and proteins	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026