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

Obesity Clinical Trial

— EXOPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167722
• Other study ID #: 19HH5065
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2021
• Source: Imperial College London
• Contact: Joseph Tam, MBBCh
• Phone: +442075942135
• Email: j.tam18[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

• Patients unable to consent

Related Conditions & MeSH terms

• Obesity
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Robotic Radical Prostatectomy
Routine NHS Radical Prostatectomy

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital, Imperial College Healthcare NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Experimental Cancer Medicine Centres, Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine functional differences of peri-prostatic adipose tissue from lean vs obese patients on prostate cancer cell lines	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
Primary	Identification of exosomal small RNAs transferred between human adipose tissue to prostate cancer cells lines	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
Primary	Assess how exosomal small RNAs from lean vs obese patients affect cancer regulation	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
Primary	Attempt to replicate functional changes observed	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

External Links

•   EXOPRO Study Website