7 Tesla MRI Scan for Cognitive Impairment in Prostate Cancer

Overseen By Bhushan Desai

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern California

Must be taking: Androgen deprivation

Must not be taking: Narcotics, Psychiatric medications

Disqualifiers: Dementia, Neuropsychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other places in the body (non-metastatic) and who have or have not received androgen deprivation therapy (ADT). The MRI machine uses a strong magnet and radio wave to make images of the inside of the body. A stronger magnetic field allows greater signals and more detailed visualization of the structure and function of human body. Giving 7 Tesla MRI may help doctors learn if patients that receive ADT show more signs of cognitive dysfunction or brain fog compared to patients to patients that do not receive ADT.

Research Team

Mark S Shiroishi, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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.

Inclusion Criteria

I have prostate cancer that has not spread and I've never had hormone therapy.

I have prostate cancer that has not spread and am currently on hormone therapy.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

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

I have only used ADT, narcotics, or psychiatric meds for my cancer.

History of dementia or other neuropsychiatric disease

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo 7 Tesla MRI over 30-90 minutes to assess baseline brain structural and functional connectivity, and metabolic profiles

1 day

1 visit (in-person)

Follow-up Assessment

Participants undergo 7 Tesla MRI over 30-90 minutes at 6-9 months to observe longitudinal changes in brain connectivity and metabolic profiles

6-9 months

1 visit (in-person)

Follow-up

Participants are monitored for changes in cognitive measures and correlation with testosterone and PSA levels

Up to 1 year

Treatment Details

Interventions

• 7 Tesla Magnetic Resonance Imaging

Trial Overview 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.

Participant Groups

Group I: Diagnostic (7 Tesla MRI) Experimental Treatment 1 Intervention

Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+