An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer
NCT ID: NCT04318028
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2020-08-11
2023-05-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MRI in Diagnosing Prostate Cancer
NCT01292291
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum
NCT05384002
Prostate Imaging Using MRI +/- Contrast Enhancement
NCT04571840
Strength, Aging, and Memory in Prostate Cancer
NCT04852224
Using Magnetic Resonance Imaging (MRI) to Guide Differential-Dose Prostate Brachytherapy
NCT01913197
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diagnostic (7 Tesla MRI)
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.
7 Tesla Magnetic Resonance Imaging
Undergo 7 Tesla MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
7 Tesla Magnetic Resonance Imaging
Undergo 7 Tesla MRI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark S Shiroishi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2019-05018
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-19-4
Identifier Type: OTHER
Identifier Source: secondary_id
4P-19-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.