CompletedNot Applicable

An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer

United States20 participantsStarted 2020-08-11

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain structural connectivity

Timeframe: Up to 1 year

Brain functional connectivity

Timeframe: Up to 1 year

Brain metabolic profiles

Timeframe: Up to 1 year

Trial details

NCT IDNCT04318028

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-11

View on ClinicalTrials.gov More Non-Metastatic Prostate Carcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.