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

Not Applicable

Completed

• Conditions: Stage IIIA Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Non-Metastatic Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8
• Interventions: Procedure: 7 Tesla Magnetic Resonance Imaging

• Registration Number: NCT04318028
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Study Start: 2020-08-11
• Primary Completion: 2023-04-11
• Study Completion: 2023-05-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (7 Tesla MRI)	7 Tesla Magnetic Resonance Imaging	Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.

Primary Outcome Measures

Name	Time	Method
Brain structural connectivity	Up to 1 year	Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain functional connectivity	Up to 1 year	Will be measured using resting-state functional MRI.
Brain metabolic profiles	Up to 1 year	Will be evaluated by MR spectroscopy.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States