- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02453139
Exercise, Prostate Cancer and Circulating Tumour Cells (ExPeCT)
Evasion of Immune Editing by Circulating Tumour Cells in an Exercise Modifiable Mechanism Underlying Aggressive Behaviour in Obese Men With Prostate Cancer
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige
- Guy's St Thomas
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Dublin, Irland
- Beaumont Hospital
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Dublin, Irland
- Mater Misericordiae University Hospital
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Dublin, Irland, 8
- St James's Hospital
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Dublin, Irland
- St Luke's Hospital
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Dublin
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Tallaght, Dublin, Irland, 24
- Adelaide and Meath Incorporating the National Children's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written informed consent obtained before any study-related procedures
- Age ≥ 18 years and male
- Histologically confirmed diagnosis of prostate adenocarcinoma
- Metastatic disease as confirmed by CT/MRI or by bone scan
- Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to randomisation
- Capable of participating safely in the proposed exercise intervention as assessed and signed off by a treating physician involved in ExPeCT recruitment.
Exclusion Criteria:
- No history of radical prostatectomy
- No previous diagnosis of any other malignant tumour (patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded provided they have undergone complete resection)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Exercise group
6 month supervised and home based moderate intensity aerobic exercise programme
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6 month supervised and home based aerobic exercise intervention
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Ingen indgriben: Control
Non-exercising control group receiving usual care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Platelet cloaking of Circulating Tumour Cells
Tidsramme: Change from baseline in platelet cloaking of circulating tumours cells at 3 months and 6 months
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Enumeration of circulating tumour cells and degree of platelet cloaking of CTCs
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Change from baseline in platelet cloaking of circulating tumours cells at 3 months and 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in systemic inflammation
Tidsramme: Change in cytokines from baseline in inflammation at 3 months and 6 months
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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
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Change in cytokines from baseline in inflammation at 3 months and 6 months
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Change in Quality of Life Questionnaire
Tidsramme: Change from baseline in quality of life at 3 months and 6 months
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Participants will complete quality of life questionnaires assessing a range of issues including sleep, diet quality and physical activity at each assessment
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Change from baseline in quality of life at 3 months and 6 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Stephen Finn, University of Dublin, Trinity College
Publikationer og nyttige links
Generelle publikationer
- Brady L, Hayes B, Sheill G, Baird AM, Guinan E, Stanfill B, Vlajnic T, Casey O, Murphy V, Greene J, Allott EH, Hussey J, Cahill F, Van Hemelrijck M, Peat N, Mucci L, Cunningham M, Grogan L, Lynch T, Manecksha RP, McCaffrey J, O'Donnell D, Sheils O, O'Leary J, Rudman S, McDermott R, Finn S. Platelet cloaking of circulating tumour cells in patients with metastatic prostate cancer: Results from ExPeCT, a randomised controlled trial. PLoS One. 2020 Dec 18;15(12):e0243928. doi: 10.1371/journal.pone.0243928. eCollection 2020.
- Sheill G, Guinan E, Neill LO, Hevey D, Hussey J. The views of patients with metastatic prostate cancer towards physical activity: a qualitative exploration. Support Care Cancer. 2018 Jun;26(6):1747-1754. doi: 10.1007/s00520-017-4008-x. Epub 2017 Dec 14.
- Sheill G, Brady L, Guinan E, Hayes B, Casey O, Greene J, Vlajnic T, Cahill F, Van Hemelrijck M, Peat N, Rudman S, Hussey J, Cunningham M, Grogan L, Lynch T, Manecksha RP, McCaffrey J, Mucci L, Sheils O, O'Leary J, O'Donnell DM, McDermott R, Finn S. The ExPeCT (Examining Exercise, Prostate Cancer and Circulating Tumour Cells) trial: study protocol for a randomised controlled trial. Trials. 2017 Oct 4;18(1):456. doi: 10.1186/s13063-017-2201-3.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202370
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