Mild Cognitive Impairment in Men Following Androgen Deprivation
Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
MCI with ageing is thought in part to be related to reduced serum sex hormones which is
well-recognised, 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 pilot study will quantify the extent of MCI in men receiving ADT with LHRHa
and oestrogen to inform the design of a larger study to understand mechanisms, predict
affected patients and determine ways of reducing MCI. Researching relationships of sex
hormones and MCI should improve understanding and interventions for slowing/preventing MCI in
PCa survivors. HRT in women slows MCI. Alternatives for ADT include parenteral oestrogen. The
PATCH clinical trial comparing transdermal oestrogen with LHRHa offers an opportunity to
assess oestrogen as preventative for male MCI. Functional magnetic resonance imaging (fMRI),
quantitative electroencephalography (qEEG) and neuropsychological tests will be used to test
this hypothesis.