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

Recruiting

• Conditions: Prostate Cancer; Obesity
• Interventions: Procedure: Robotic Radical Prostatectomy

• Registration Number: NCT04167722
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• All men undergoing radical prostatectomy at Charing Cross Hospital

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Exclusion Criteria

• Patients unable to consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients	Robotic Radical Prostatectomy	BMI \> 25
Lean patients	Robotic Radical Prostatectomy	BMI \< or = 25

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Charing Cross Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom