Androgen Deprivation Therapy (ADT) is associated with cognitive impairment and dementia in men with prostate cancer. Pre-clinical data suggest that ADT-induced hypogonadism leads to accumulation of beta-amyloid plaques in the hippocampus, a pathological hallmark of Alzheimer's Disease (AD). Neuroimaging Functional magnetic resonance imaging (fMRI) studies also demonstrate that ADT decreases metabolic activity in the parietal, occipital, and prefrontal cortices. Multiple prospective cohort and population-based clinical studies have been conducted to test the association between ADT and cognitive impairment and/or dementia. Plasma biomarkers have been developed to predict brain amyloidosis, a key pathological feature of AD and a risk factor for developing dementia due to AD. The advantage of a blood-based assay is the lower cost, invasiveness, and time compared to cerebrospinal fluid (CSF) and Positron Emission Tomography (PET)-based biomarkers.
This is a single-site, non-randomized prospective observational study of men with prostate cancer. PRIMARY OBJECTIVE: I. To evaluate whether baseline plasma Amyloid-beta 42/40 (Aβ42/40) ratio is associated with cognitive decline in men upon starting ADT. SECONDARY OBJECTIVE: I. To evaluate whether ADT is associated with a decline in plasma Aβ42/40 ratio. II. To evaluate whether intensified ADT (iADT) receipt is associated with greater cognitive decline compared to ADT.
Study Type
OBSERVATIONAL
Enrollment
32
Blood samples will be collected
Cognitive assessments will be both participant- and partner-reported
Participant-reported Quality of Life Surveys
University of California, San Francisco
San Francisco, California, United States
Proportion of participants with cognitive decline (ADT cohort)
Proportion with cognitive decline, defined as a decrease in \>=1 neurocognitive test after ADT by \>=1 standard deviation (SD) compared to baseline.
Time frame: Up to 12 months
Mean cognitive decline (ADT cohort)
The Z-scores of each cognitive test after receiving ADT will be calculated as a repeated measure.
Time frame: Up to 12 months
Proportion of participants with cognitive impairment after ADT (ADT Cohort)
Proportion of participants with cognitive impairment after receiving ADT, defined as a score of \>=1 SD below normative mean score (i.e., PC control) in \>=1 of the neurocognitive tests given during the course of ADT therapy.
Time frame: Up to 12 months
Change in mean plasma Aβ42/40 ratio
Change in mean plasma Aβ42/40 ratio for the ADT cohort at 12 months will be compared to that of the PC control cohort
Time frame: Up to 12 months
Mean cognition score
The Z-scores of each cognitive test will be calculated as a repeated measure.
Time frame: Up to 12 months
Mean study partner-reported cognition score
The Z-scores of each cognitive test will be calculated as a repeated measure.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.