Clinical trial NCT04318028: 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
Overall status: COMPLETED
Phase: NA
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
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Brain structural connectivity
timeFrame: Up to 1 year
measure: Brain functional connectivity
timeFrame: Up to 1 year
measure: Brain metabolic profiles
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
measure: Assessment of testosterone and prostate specific antigen (PSA) levels
timeFrame: Up to 1 year
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Mark S Shiroishi, MD
role: PRINCIPAL_INVESTIGATOR
References: