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

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04167722
Collaborator
Imperial College Healthcare NHS Trust (Other), Experimental Cancer Medicine Centres (Other)
100
1
60
1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Robotic Radical Prostatectomy

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The EXOPRO Study: How Does Prostate Cancer Metastasize? Understanding the Role of Exosomal Communication in Lean vs Obese Patients
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Determine functional differences of peri-prostatic adipose tissue from lean vs obese patients on prostate cancer cell lines [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

  2. Identification of exosomal small RNAs transferred between human adipose tissue to prostate cancer cells lines [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

  3. Assess how exosomal small RNAs from lean vs obese patients affect cancer regulation [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

  4. Attempt to replicate functional changes observed [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All men undergoing radical prostatectomy at Charing Cross Hospital
Exclusion Criteria:
  • Patients unable to consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charing Cross Hospital, Imperial College Healthcare NHS Trust London United Kingdom W68RF

Sponsors and Collaborators

  • Imperial College London
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT04167722
Other Study ID Numbers:
  • 19HH5065
First Posted:
Nov 19, 2019
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021