- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318028
An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer
A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment
Study Overview
Status
Conditions
- Stage I Prostate Cancer AJCC v8
- Stage II Prostate Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
- Stage IIC Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IIIC Prostate Cancer AJCC v8
- Stage IIA Prostate Cancer AJCC v8
- Stage IIB Prostate Cancer AJCC v8
- Non-Metastatic Prostate Carcinoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Observe longitudinal changes in structural connectivity using T1-weighted and diffusion tensor MRI in men with non-metastatic prostate cancer on current ADT versus those who were not.
II. Observe longitudinal changes in brain functional connectivity using resting-state functional (rsf) MRI.
III. Observe longitudinal changes in brain metabolic profiles evaluated by MR spectroscopy (MRS).
IV. Exploratory assessment of correlation between testosterone and prostate specific antigen (PSA) levels with MRI measures and cognitive measures.
SECONDARY OBJECTIVES:
I. To assess the feasibility and acceptability of this approach using sequential 7T MRI in prostate cancer patients either receiving ADT or not.
OUTLINE:
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and at 6-9 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent
- Group 1 (G1): Non-metastatic biopsy-proven prostate cancer patients on current ADT and
- Group 2 (G2): Demographically (age, cancer stage) matched non-metastatic biopsy proven prostate cancer patients without a history of ADT
- Ability to undergo imaging procedure without any form of sedation
- Ability to complete brief cognitive testing on iPad
Exclusion Criteria:
- History of dementia or other neuropsychiatric disease
- History of other cancer medical therapies other than ADT, narcotics or psychiatric medications
Standard contraindications for MRI:
- Prior work as a machinist or metal worker, or history of metal being removed from the eyes,
- Cardiac pacemaker or internal pacing wires,
- Non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or
- Claustrophobia, or uncontrollable motion disorder
- Currently active second malignancy
- Any significant cardiovascular conditions (New York Heart Association [NYHA]) class III or IV congestive heart failure, myocardial infarction within 6 months, unstable angina, pacemaker); or
- Renal disease with calculated creatinine clearance of < 45 ml/min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (7 Tesla MRI)
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.
|
Undergo 7 Tesla MRI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain structural connectivity
Time Frame: Up to 1 year
|
Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
|
Up to 1 year
|
Brain functional connectivity
Time Frame: Up to 1 year
|
Will be measured using resting-state functional MRI.
|
Up to 1 year
|
Brain metabolic profiles
Time Frame: Up to 1 year
|
Will be evaluated by MR spectroscopy.
|
Up to 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of testosterone and prostate specific antigen (PSA) levels
Time Frame: Up to 1 year
|
For the correlation of between testosterone and PSA levels with MRI measures and cognitive measures, the study will use scatter plots to explore the pattern of correlation.
Spearmen's correlation will be used to test the correlation.
Both groups will be combined for the correlation analysis.
|
Up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark S Shiroishi, MD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4P-19-4 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2019-05018 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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