Non-Metastatic Prostate CarcinomaNCT04318028
An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer
A study testing 7 Tesla Magnetic Resonance Imaging in people with Non-Metastatic Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by University of Southern California at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-Metastatic Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- 7 Tesla Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 17 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Non-Metastatic Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
- Being tested
- 7 Tesla Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called 7 Tesla MRI, 7T MRI
Undergo 7 Tesla MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (7 Tesla MRI) | Experimental | Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months. Receives: Procedure: 7 Tesla Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structural connectivity
Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Measured: Up to 1 year
Brain functional connectivity
Will be measured using resting-state functional MRI.
Measured: Up to 1 year
Brain metabolic profiles
Will be evaluated by MR spectroscopy.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start11 Aug 2020
- Primary completion11 Apr 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Metastatic Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark S Shiroishi, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318028
- Sponsor's protocol ID
- 4P-19-4
- Other IDs
- NCI-2019-05018, 4P-19-4, P30CA014089
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2020
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04318028
- Acronym / sponsor ID
- 4P-19-4
- Conditions
- Non-Metastatic Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (7 Tesla MRI) | Experimental | Procedure: 7 Tesla Magnetic Resonance ImagingPatients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- History of dementia or other neuropsychiatric disease
- History of other cancer medical therapies other than ADT, narcotics or psychiatric medications
- Standard contraindications for MRI:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 Tesla Magnetic Resonance ImagingAlso: 7 Tesla MRI, 7T MRIUndergo 7 Tesla MRI | Procedure or surgery | Diagnostic (7 Tesla MRI) |
Primary outcome
Brain structural connectivity
Time frame: Up to 1 year
Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain functional connectivity
Time frame: Up to 1 year
Will be measured using resting-state functional MRI.
Brain metabolic profiles
Time frame: Up to 1 year
Will be evaluated by MR spectroscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Shiroishi, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 Tesla Magnetic Resonance Imaging in people with Non-Metastatic Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structural connectivity (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.