Study Stopped
No one recruited due to resource limitations. Issues with how complicated the study could be for patients so the study was later modified and turned into a different study.
Mild Cognitive Impairment in Men Following Androgen Deprivation
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2012
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 20, 2020
November 1, 2020
1.2 years
September 11, 2012
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective evaluation of mild cognitive impairment on parietal fMRI signals
The primary outcome measure is the development of MCI following ADT with LHRHa, as evaluated by fMRI. The group change in the parietal blood oxygen level-dependent echoplanar imaging (BOLD EPI) fMRI signal associated with a three-dimensional rotation cognitive activation task at six-month follow-up compared with baseline.
6 months
Secondary Outcomes (4)
Objective evaluation of mild cognitive impairment on non-parietal fMRI signals
6 months
Electroencephalographic evaluation of mild cognitive impairment
6 months
Subjective evaluation of mild cognitive impairment by CANTAB
6 months
Subjective evaluation of mild cognitive impairment by ADAS-cog
6 months
Other Outcomes (6)
Serum testosterone levels
6 months
Serum oestradiol levels
6 months
Serum luteinising hormone levels
6 months
- +3 more other outcomes
Study Arms (3)
Controls
NO INTERVENTIONAge-matched male patients with benign prostatic hyperplasia, otherwise healthy, as controls
LHRHa
ACTIVE COMPARATORProstate cancer patients receiving androgen deprivation therapy by luteinising hormone releasing-hormone agonists (LHRHa)
Oestrogen
EXPERIMENTALProstate cancer patients recruited from the Prostate Adenocarcinoma TransCutaneous Hormones (PATCH) Trial, randomised to receive ADT via transdermal oestrogen patches.
Interventions
Eligibility Criteria
You may qualify if:
- Male patients between the ages 50 to 90 years beginning ADT with LHRHa or PATCH participants randomised to either LHRHa or transdermal oestrogen for either newly diagnosed advanced prostate cancer or previously treated with radical radiotherapy or surgery and now having a rising prostate specific antigen will be included in the study.
You may not qualify if:
- Patients with a known history of dementia will be excluded as well as those patients who have received any prior hormone therapy for localised prostate cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Healthcare NHS Trust
London, W12 0NN, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul D Abel, ChM, FRCS
Imperial College London and Imperial College Healthcare NHS Trust
- PRINCIPAL INVESTIGATOR
Syed IA Shah, MBBS, MPhil
Imperial College London and Imperial College Healthcare NHS Trust
- PRINCIPAL INVESTIGATOR
Adam Waldman
Imperial College Healthcare NHS Trust
- PRINCIPAL INVESTIGATOR
Basant K Puri
Imperial College Healthcare NHS Trust
- PRINCIPAL INVESTIGATOR
Pat Price
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 25, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 20, 2020
Record last verified: 2020-11