NCT02453139

Brief Summary

Obesity, known to be associated with a pro-inflammatory, pro-thrombotic humoral milieu, confers a worse prognosis in prostate cancer (PrCa). Circulating tumour cells (CTCs) are identified in the blood in advanced cancer. Their quantitation provides prognostic information. "Cloaking" of CTCs by adherent platelets impedes natural killer (NK)-cell clearance of CTCs from the circulation, enhancing metastatic spread. NK-cell function in blood and in solid organs is quantitatively and qualitatively reduced in obesity. Platelet cloaking may be enhanced in obesity due to the pro-inflammatory, pro-thrombotic state, and may be a mechanism for worse cancer-specific outcomes in this group. Obesity and its biochemical effects may be influenced by lifestyle changes such as exercise. Physical activity reduces levels of systemic inflammatory mediators and so an aerobic exercise intervention may represent an accessible and cost-effective means of ameliorating the pro-inflammatory effects of obesity. The ExPeCT trial will determine if a prescribed exercise intervention can ameliorate the degree of platelet cloaking in obese and non-obese men with advanced prostate cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2014

Geographic Reach
2 countries

6 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

2.7 years

First QC Date

May 12, 2015

Last Update Submit

May 1, 2018

Conditions

Prostate CancerObesity

Outcome Measures

Primary Outcomes (1)

  • Change in Platelet cloaking of Circulating Tumour Cells

    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

Secondary Outcomes (2)

  • Change in systemic inflammation

    Change in cytokines from baseline in inflammation at 3 months and 6 months

  • Change in Quality of Life Questionnaire

    Change from baseline in quality of life at 3 months and 6 months

Study Arms (2)

Exercise group

EXPERIMENTAL

6 month supervised and home based moderate intensity aerobic exercise programme

Behavioral: Exercise

Control

NO INTERVENTION

Non-exercising control group receiving usual care

Interventions

ExerciseBEHAVIORAL

6 month supervised and home based aerobic exercise intervention

Exercise group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Adelaide and Meath Incorporating the National Children's Hospital

Tallaght, Dublin, 24, Ireland

Location

St James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

St Luke's Hospital

Dublin, Ireland

Location

Guy's St Thomas

London, United Kingdom

Location

Related Publications (4)

  • Sheill G, Brady L, Hayes B, Baird AM, Guinan E, Vishwakarma R, Brophy C, Vlajnic T, Casey O, Murphy V, Greene J, Allott E, 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. ExPeCT: a randomised trial examining the impact of exercise on quality of life in men with metastatic prostate cancer. Support Care Cancer. 2023 Apr 22;31(5):292. doi: 10.1007/s00520-023-07740-4.

    PMID: 37086362DERIVED

  • 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.

    PMID: 33338056DERIVED

  • 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.

    PMID: 29243168DERIVED

  • 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.

    PMID: 28978344DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen Finn

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 25, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

GB(1)IE(5)