Exercise, Prostate Cancer and Circulating Tumour Cells (ExPeCT)
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|ClinicalTrials.gov Identifier: NCT02453139|
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Obesity||Behavioral: Exercise||Not Applicable|
The overarching hypothesis is that enhanced platelet cloaking of circulating tumour cells in obese men with prostate cancer, due to increased systemic inflammation, is a mechanism underlying worse prognosis of cancer in these patients.
The investigators aim to test the following four hypotheses, dividing the experimental and analytical work into four separate projects.
- Platelet cloaking of circulating PrCa tumour cells is more prominent in men with obesity than without
- Regular exercise can ameliorate platelet cloaking
- The degree of platelet cloaking varies with levels of systemic and primary tumour inflammation and coagulability
- Expression of an obesity-associated lethality gene signature leads to variation in platelet cloaking
For the first hypothesis, 200 men with metastatic PrCa will be recruited, and divided into exposed and non-exposed groups based on body mass index (BMI >25). The objective will be to enumerate CTCs and quantify the degree of platelet cloaking in exposed and non-exposed groups, and to draw meaningful comparisons between the two.
For the second hypothesis, the objective will be to determine to what extent the number of CTCs and the degree of platelet cloaking varies in exposed and non-exposed groups following a supervised exercise intervention, and to compare this with a non-exercised comparison group. The exercise intervention will prescribe moderate intensity aerobic exercise that will be supervised once per week for 3 months and completed independently at home for a further 3 months. Patients will wear Polar heart rate monitors to monitor exercise prescription and progression. Assessments including blood sampling and quality of life questionnaires will be completed at baseline, 3 months and 6 months.
For the third hypothesis, the objective will be to build a serological, haematological and immunological picture of the state of systemic inflammation and coagulability, and the degree of inflammation within the prostate gland. Furthermore, the investigators intend to correlate and compare these variables with the results of the first and second objectives, in order to determine whether the number of CTCs and the degree of platelet cloaking varies with changes in the inflammatory / coagulatory milieu.
For the fourth hypothesis, the objective will be to determine whether the expression profile of a number of lethality-associated genes, known to be associated with PrCa progression, coagulation and stem-cell like phenotype, correlates with the number of CTCs and the degree of their cloaking by platelets.
CTC numbers and the degree of platelet cloaking will be common denominators which anchor these four objectives together and enable comparison between them.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evasion of Immune Editing by Circulating Tumour Cells in an Exercise Modifiable Mechanism Underlying Aggressive Behaviour in Obese Men With Prostate Cancer|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Exercise group
6 month supervised and home based moderate intensity aerobic exercise programme
6 month supervised and home based aerobic exercise intervention
No Intervention: Control
Non-exercising control group receiving usual care
- Change in Platelet cloaking of Circulating Tumour Cells [ Time Frame: Change from baseline in platelet cloaking of circulating tumours cells at 3 months and 6 months ]Enumeration of circulating tumour cells and degree of platelet cloaking of CTCs
- Change in systemic inflammation [ Time Frame: Change in cytokines from baseline in inflammation at 3 months and 6 months ]Blood samples will be taken from participants at each assessment and analysed by multi-plex assays for levels of cytokines (TNF-alpha and interleukin (IL)-6
- Change in Quality of Life Questionnaire [ Time Frame: Change from baseline in quality of life at 3 months and 6 months ]Participants will complete quality of life questionnaires assessing a range of issues including sleep, diet quality and physical activity at each assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453139
|Adelaide and Meath Incorporating the National Children's Hospital|
|Tallaght, Dublin, Ireland, 24|
|St James's Hospital|
|Dublin, Ireland, 8|
|Mater Misericordiae University Hospital|
|St Luke's Hospital|
|Guy's St Thomas|
|London, United Kingdom|
|Principal Investigator:||Stephen Finn||Trinity College Dublin|