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7 Tesla MRI Scan for Cognitive Impairment in Prostate Cancer

N/A
Waitlist Available
Led By Mark S Shiroishi, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group 2 (G2): Demographically matched non-metastatic biopsy proven prostate cancer patients without a history of ADT
Group 1 (G1): Non-metastatic biopsy-proven prostate cancer patients on current ADT
Must not have
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
History of other cancer medical therapies other than ADT, narcotics or psychiatric medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how well 7 Tesla MRI works in diagnosing cognitive impairment in patients with non-metastatic prostate cancer who have or have not received ADT.

Who is the study for?
This trial is for men with non-metastatic prostate cancer, divided into two groups: those currently on androgen deprivation therapy (ADT) and those who've never had ADT. Participants must be able to consent, complete cognitive tests on an iPad, and have no severe kidney issues or incompatible medical devices like pacemakers. They shouldn't have heart failure, recent heart attacks, other active cancers, a history of metal work in the eyes or dementia.
What is being tested?
The study is testing if a high-powered MRI scan called 7 Tesla can detect cognitive changes in patients with prostate cancer. It compares brain images from patients receiving ADT to those not on this treatment to see if there's more 'brain fog' or cognitive dysfunction associated with ADT.
What are the potential side effects?
While the 7 Tesla MRI itself doesn't involve medication and thus has minimal side effects, it may cause discomfort due to loud noises during scanning or feelings of claustrophobia. Patients with certain implants cannot participate due to magnetic interference.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have prostate cancer that has not spread and I've never had hormone therapy.
Select...
I have prostate cancer that has not spread and am currently on hormone therapy.
Select...
I can have imaging tests without needing sedation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have only used ADT, narcotics, or psychiatric meds for my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain functional connectivity
Brain metabolic profiles
Brain structural connectivity
Other study objectives
Assessment of testosterone and prostate specific antigen (PSA) levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (7 Tesla MRI)Experimental Treatment1 Intervention
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,625 Total Patients Enrolled
12 Trials studying Prostate Cancer
9,224 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,931 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Mark S Shiroishi, MDPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

7 Tesla Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04318028 — N/A
Prostate Cancer Research Study Groups: Diagnostic (7 Tesla MRI)
Prostate Cancer Clinical Trial 2023: 7 Tesla Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT04318028 — N/A
7 Tesla Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318028 — N/A
~4 spots leftby Nov 2025
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