Prostate CancerMRSI+RRPNCT01780701
Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer
An observational study of Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Magnetic Resonance Spectroscopy Imaging with rectal probe
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: all men newly-diagnosed with prostate cancer at the Portland VA and OHSU Urology clinics
Who may be able to join
- Prostate cancer diagnosis prior to treatment
- Age 21 years or older
- Signed informed subject consent
- Prostatectomy as planned prostate cancer treatment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Portland VA Medical Center
Portland, Oregon, 97207
Oregon Health & Science University Advanced Imaging Research Center
Portland, Oregon, 97239
About this study
Official title: Imaging Prostatic Lipids to Distinguish Aggressive 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.
- Conditions
- Prostate Cancer
- Being tested
- Magnetic Resonance Spectroscopy Imaging with rectal probe
- Keywords
- prostate cancer aggressiveness, magnetic resonance imaging, fatty acid synthase
- Medical subject headings
- Prostatic Neoplasms, Prostate Cancer, Hereditary, 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Spectroscopy Imaging with rectal probeProcedure or surgery
Also called Magnetic Resonance Spectroscopy Imaging, MRSI, Magnetic Resonance Imaging, MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe | |
| 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. Receives: Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with increased intraprostatic lipid concentration
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.
Measured: Up to 3 years
Secondary outcomes (1)
Number of participants with increased tumor aggressiveness
Identify the association between fatty acid synthase protein expression in prostatectomy samples, intraprostatic lipid as measured by 1H MRSI, and prostate tumor aggressiveness.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Portland VA Medical Center, Oregon Health and Science University
- Responsible party
- Principal investigator, Jackie Shannon, OHSU Knight Cancer Institute
- Investigators
- Jackilen Shannon, PhD, Principal investigator, Oregon Health and Science UniversityJonathan Q Purnell, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780701
- Sponsor's protocol ID
- IRB00008458
- Other IDs
- W81XWH-12-1-0168, 2978, 8458, Log #A-17208, PC110361
- Acronym
- MRSI+RRP
- Status last verified
- Nov 2016
- First submitted
- 7 Jan 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer
- ClinicalTrials.gov ID
- NCT01780701
- Acronym / sponsor ID
- MRSI+RRP / IRB00008458
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer aggressiveness, magnetic resonance imaging, fatty acid synthase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense, Portland VA Medical Center, Oregon Health and Science University
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk prostate cancer patients | – | Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probeMen 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. |
| Low risk prostate cancer patients | – | Procedure: Magnetic Resonance Spectroscopy Imaging with rectal probeMen 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all men newly-diagnosed with prostate cancer at the Portland VA and OHSU Urology clinics
Key inclusion criteria (4 listed)
- Prostate cancer diagnosis prior to treatment
- Age 21 years or older
- Signed informed subject consent
- Prostatectomy as planned prostate cancer treatment
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Spectroscopy Imaging with rectal probeAlso: Magnetic Resonance Spectroscopy Imaging, MRSI, Magnetic Resonance Imaging, MRI | Procedure or surgery | High risk prostate cancer patients, Low risk prostate cancer patients |
Primary outcome
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.
1 secondary outcome
Number of participants with increased tumor aggressiveness
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackilen Shannon, PhD principal investigator
Oregon Health and Science University
Jonathan Q Purnell, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with increased intraprostatic lipid concentration (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.