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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Exercise group
6 month supervised and home based moderate intensity aerobic exercise programme
|
6 month supervised and home based aerobic exercise intervention
|
|
介入なし:Control
Non-exercising control group receiving usual care
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Platelet cloaking of Circulating Tumour Cells
時間枠: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 from baseline in platelet cloaking of circulating tumours cells at 3 months and 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in systemic inflammation
時間枠: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 cytokines from baseline in inflammation at 3 months and 6 months
|
|
Change in Quality of Life Questionnaire
時間枠: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
|
Change from baseline in quality of life at 3 months and 6 months
|
協力者と研究者
捜査官
- 主任研究者:Stephen Finn、University of Dublin, Trinity College
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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