NCT04318028

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

March 19, 2020

Last Update Submit

March 13, 2025

Conditions

Non-Metastatic Prostate CarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

  • Brain structural connectivity

    Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).

    Up to 1 year

  • Brain functional connectivity

    Will be measured using resting-state functional MRI.

    Up to 1 year

  • Brain metabolic profiles

    Will be evaluated by MR spectroscopy.

    Up to 1 year

Other Outcomes (1)

  • Assessment of testosterone and prostate specific antigen (PSA) levels

    Up to 1 year

Study Arms (1)

Diagnostic (7 Tesla MRI)

EXPERIMENTAL

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

Procedure: 7 Tesla Magnetic Resonance Imaging

Interventions

7 Tesla Magnetic Resonance ImagingPROCEDURE

Undergo 7 Tesla MRI

Also known as: 7 Tesla MRI, 7T MRI
Diagnostic (7 Tesla MRI)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mark S Shiroishi, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

August 11, 2020

Primary Completion

April 11, 2023

Study Completion

May 17, 2023

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

US(1)