How Does Prostate Cancer Metastasize? Studying the Role of Secreted Packages (Exosomes) From Fat Tissue in Lean and Obese Patients (EXOPRO)

September 21, 2021 updated by: Imperial College London

The EXOPRO Study: How Does Prostate Cancer Metastasize? Understanding the Role of Exosomal Communication in Lean vs Obese Patients

The investigators will be collecting prostate and fat tissue from participants undergoing radical prostatectomy to culture and study in the laboratory.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Both obesity and prostate cancer are major health problems in the UK, affecting 1 in 3 and 1 in 8 men respectively. Moreover, obesity increases the risk of developing aggressive disease and the risk of prostate cancer spreading. How this happens is not known. The investigators want to understand how fat cells communicate with prostate cancer cells. Investigators will be collecting prostate and fat tissue from radical prostatectomy participants for culture, in particular to look at exosome communication.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W68RF
        • Recruiting
        • Charing Cross Hospital, Imperial College Healthcare NHS Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mathias Winkler, FRCS
        • Principal Investigator:
          • Joseph Tam, MBBCh
        • Principal Investigator:
          • Charlotte Bevan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Obese vs lean patients

Description

Inclusion Criteria:

  • All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

  • Patients unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese patients
BMI > 25
Procedure: Robotic Radical Prostatectomy
Routine NHS Radical Prostatectomy
Lean patients
BMI < or = 25
Procedure: Robotic Radical Prostatectomy
Routine NHS Radical Prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine functional differences of peri-prostatic adipose tissue from lean vs obese patients on prostate cancer cell lines
Time Frame: Through to study completion, on average 3 years
Proliferation, migration, invasion, apoptosis and epthelial-mesenchymal transition assays will be performed using isolated exosomes on prostate cancer cell lines
Through to study completion, on average 3 years
Identification of exosomal small RNAs transferred between human adipose tissue to prostate cancer cells lines
Time Frame: Through to study completion, on average 3 years
Exosomal RNA transferred from human adipose tissue to prostate cancer cell lines will be isolated using a tagged magnetic bead isolation method and sequenced to identify transferred small RNAs
Through to study completion, on average 3 years
Assess how exosomal small RNAs from lean vs obese patients affect cancer regulation
Time Frame: Through to study completion, on average 3 years
Prostate cancer cell lines will be treated with isolated exosomes, then parental and treated cells sequenced to identify differentially expressed RNA and underlying changes
Through to study completion, on average 3 years
Attempt to replicate functional changes observed
Time Frame: Through to study completion, on average 3 years
Treatment of prostate cancer cell lines with microRNA mimics or inhibitors and comparison of changes with exosome treated cell lines
Through to study completion, on average 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Imperial College Healthcare NHS Trust
Experimental Cancer Medicine Centres

Investigators

  • Principal Investigator: Charlotte Bevan, PhD, Imperial College London
  • Principal Investigator: Mathias Winkler, FRCS, Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19HH5065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcomes will be made available.

IPD Sharing Time Frame

Data will be available within 6 to 12 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Regulators will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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