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

NCT04167722 | Unknown

• 1 other identifier: 19HH5065
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Obesity

Keywords

Prostate Cancer; Obesity; Exosomes

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Obese patients

BMI \> 25

Procedure: Robotic Radical Prostatectomy

Lean patients

BMI \< or = 25

Procedure: Robotic Radical Prostatectomy

Interventions

Robotic Radical Prostatectomy PROCEDURE

Routine NHS Radical Prostatectomy

Lean patients; Obese patients

Eligibility Criteria

• Gender Eligibility Details: Biological male only (can include transgender women)
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese vs lean patients

You may qualify if:

• All men undergoing radical prostatectomy at Charing Cross Hospital

You may not qualify if:

• Patients unable to consent

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Experimental Cancer Medicine Centres: collaborator

Study Sites (1)

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, W68RF, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Prostate cancer tissue, benign prostate tissue, peri-prostatic adipose tissue, omental adipose tissue, blood, urine

MeSH Terms

Conditions

Prostatic Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte Bevan, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Mathias Winkler, FRCS

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Tam, MBBCh

CONTACT

+442075942135; j.tam18@imperial.ac.uk

Becky Ward

CONTACT

+442075949459; becky.ward@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 19, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 to 12 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Regulators will be required to sign a data access agreement.

Locations

GB (1)