Prostate Cancer Clinical Trial
Official title:
A PET Imaging Study to Detect the Presence of Activated Microglia in the Brains of Prostate Cancer Patients Who Develop Mild Cognitive Impairment Following Androgen Deprivation Therapy
NCT number | NCT02061345 |
Other study ID # | 13HH0558 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | January 2022 |
Verified date | November 2023 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 11 |
Est. completion date | January 2022 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Prostate cancer patients between the ages 50 to 80 years on ADT with LHRHa for for 3 months up to a year. 2. Able to give written informed consent. 3. Able to lie still for up to 90 minutes for a PET scan. 4. Not claustrophobic and so able to undergo an MRI scan. Exclusion Criteria: 1. Patients with a known history of organic brain disorders and associated dementia, delirium and other specific neuropsychiatric conditions, including stroke and head injury. 2. Patients who are clinically assessed as having MCI prior to starting ADT. 3. Patients with a medical prognosis of less than 3 months. 4. Patients who are claustrophobic. 5. Patients who have any metal implanted in their body e.g. heart pacemaker, cochlear implant or any other electronic device. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Saleem A, Shah SIA, Mangar SA, Coello C, Wall MB, Rizzo G, Jones T, Price PM. Cognitive Dysfunction in Patients Treated with Androgen Deprivation Therapy: A Multimodality Functional Imaging Study to Evaluate Neuroinflammation. Prostate Cancer. 2023 Oct 18 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cognitive Impairment | Association of cognitive and neuropsychiatric impairments following ADT with structural and/or functional brain connectivity | Single time-point | |
Primary | PET Biomarker Uptake | The outcome measure is the increased uptake of 11-Carbon Peripheral Benzodiazepine Receptor-28 ([11C]PBR28) biomarker by activated microglia of patients demonstrating significant MCI with the primary endpoint of [11C]PBR28 uptake measured as a standardized uptake value (SUV) | Single time-point SUV in Hippocampus area on the day of the test | |
Secondary | PET Biomarker Volume of Distribution | Secondary endpoint is the [11C]PBR28 total volume of distribution (VT) | Single time-point |
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