N/A
N=11
PET Imaging in MCI Following ADT for PCa
Prostate Cancer · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02061345 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: PET Biomarker Uptake — 0.95; 0.98 Standard Uptake Measure SUV
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Imperial College London
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PET Biomarker Uptake |
0.95; 0.98 | — |
| SECONDARY PET Biomarker Volume of Distribution |
— | — |
Summary
Mild cognitive impairment (MCI) with ageing is thought in part to be related to reduced serum sex hormones which is well-recognized, especially in females, but poorly understood. International studies assessing hormone replacement therapy (HRT) to prevent/reduce MCI are ongoing. MCI leads to morbidity, reduced quality of life and substantial healthcare costs. The commonest therapeutically induced reduction in sex hormone level in men is treatment of prostate cancer (PCa). PCa is androgen dependent and androgen deprivation therapy (ADT) suppressing testosterone to castrate levels is key therapy for advanced disease. About one million men worldwide have received ADT for PCa, mostly using luteinising hormone releasing hormone agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps 4% of Caucasians may be castrated. MCI as a side effect of castration in men remains poorly researched. This study aims to demonstrate that pathological changes occur in the brains of a significant proportion of prostate cancer patients subjected to ADT that correlate with MCI symptoms. Highlighting the pathological changes of MCI should improve understanding and interventions for slowing/preventing MCI in PCa survivors. Brain scans employing positron emission tomography (PET) imaging technique will be used to detect the presence of pathological changes in the brain that relate to ADT induced MCI. MCI will be assessed by neuropsychological assessments (standard paper-based questionnaires and online) and its neural basis will be investigated using magnetic resonance imaging (MRI).
Eligibility Criteria
Inclusion Criteria
- Prostate cancer patients between the ages 50 to 80 years on ADT with LHRHa for for 3 months up to a year.
- Able to give written informed consent.
- Able to lie still for up to 90 minutes for a PET scan.
- Not claustrophobic and so able to undergo an MRI scan.
Exclusion Criteria
- Patients with a known history of organic brain disorders and associated dementia, delirium and other specific neuropsychiatric conditions, including stroke and head injury.
- Patients who are clinically assessed as having MCI prior to starting ADT.
- Patients with a medical prognosis of less than 3 months.
- Patients who are claustrophobic.
- Patients who have any metal implanted in their body e.g. heart pacemaker, cochlear implant or any other electronic device.
Data sourced from ClinicalTrials.gov (NCT02061345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.