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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain functional connectivity
Brain metabolic profiles
Brain structural connectivity
Other outcome measures
Assessment of testosterone and prostate specific antigen (PSA) levels
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.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,298 Total Patients Enrolled
18 Trials studying Prostate Cancer
9,422 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,303 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Mark S Shiroishi, MDPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
210 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have only used ADT, narcotics, or psychiatric meds for my cancer.I can have imaging tests without needing sedation.I can complete short tests on an iPad.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (7 Tesla MRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being tracked in this research initiative?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial was initially opened on August 11th 2020 and has recently been updated as of August 6th 2022. A total of 10 patients are sought from a single location for enrollment in the study."
Answered by AI
Are there still openings for individuals to join this research initiative?
"According to clinicaltrials.gov this scientific trial is actively recruiting patients, having been posted on August 11th 2020 and last updated in early August 2022."
Answered by AI
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