search
Back to results

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

Primary Purpose

Non-Metastatic Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7 Tesla Magnetic Resonance Imaging
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Metastatic Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (7 Tesla MRI)

Arm Description

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

Outcomes

Primary Outcome Measures

Brain structural connectivity
Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain functional connectivity
Will be measured using resting-state functional MRI.
Brain metabolic profiles
Will be evaluated by MR spectroscopy.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2020
Last Updated
August 9, 2023
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04318028
Brief Title
An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer
Official Title
A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (7 Tesla MRI)
Arm Type
Experimental
Arm Description
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.
Intervention Type
Radiation
Intervention Name(s)
7 Tesla Magnetic Resonance Imaging
Other Intervention Name(s)
7 Tesla MRI, 7T MRI
Intervention Description
Undergo 7 Tesla MRI
Primary Outcome Measure Information:
Title
Brain structural connectivity
Description
Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Time Frame
Up to 1 year
Title
Brain functional connectivity
Description
Will be measured using resting-state functional MRI.
Time Frame
Up to 1 year
Title
Brain metabolic profiles
Description
Will be evaluated by MR spectroscopy.
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Assessment of testosterone and prostate specific antigen (PSA) levels
Description
For the correlation of between testosterone and PSA levels with MRI measures and cognitive measures, the study will use scatter plots to explore the pattern of correlation. Spearmen's correlation will be used to test the correlation. Both groups will be combined for the correlation analysis.
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Shiroishi, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs