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

University of Southern California

Status

Completed

Conditions

Stage IIIC Prostate Cancer AJCC v8

Stage I Prostate Cancer AJCC v8

Stage IIA Prostate Cancer AJCC v8

Stage IIC Prostate Cancer AJCC v8

Stage IIIB Prostate Cancer AJCC v8

Non-Metastatic Prostate Carcinoma

Stage III Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Stage IIB Prostate Cancer AJCC v8

Treatments

Procedure: 7 Tesla Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04318028

NCI-2019-05018 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

4P-19-4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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