Prostate CancerEXOPRONCT04167722
How Does Prostate Cancer Metastasize? Studying the Role of Secreted Packages (Exosomes) From Fat Tissue in Lean and Obese Patients
An observational study of Prostate Cancer and Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators will be collecting prostate and fat tissue from participants undergoing radical prostatectomy to culture and study in the laboratory. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Obesity
- What is being tested?
- Robotic Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Obese vs lean patients
Who may be able to join
- All men undergoing radical prostatectomy at Charing Cross Hospital
Who cannot join
- Patients unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, W68RF
Mathias Winkler, FRCS, +44203311234, mathias.winkler@nhs.net
Joseph Tam, MBBCh, +442075942135, j.tam18@imperial.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Obesity
- Being tested
- Robotic Radical Prostatectomy
- Keywords
- Prostate Cancer, Obesity, Exosomes
- Medical subject headings
- Prostatic Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Radical ProstatectomyProcedure or surgery
Routine NHS Radical Prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | BMI > 25 Receives: Procedure: Robotic Radical Prostatectomy | |
| Lean patients | BMI < or = 25 Receives: Procedure: Robotic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Through to study completion, on average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Experimental Cancer Medicine Centres
- Responsible party
- Sponsor
- Investigators
- Charlotte Bevan, PhD, Principal investigator, Imperial College LondonMathias Winkler, FRCS, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167722
- Sponsor's protocol ID
- 19HH5065
- Acronym
- EXOPRO
- Status last verified
- Sep 2021
- First submitted
- 11 Nov 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXOPRO Study: How Does Prostate Cancer Metastasize? Understanding the Role of Exosomal Communication in Lean vs Obese Patients
- ClinicalTrials.gov ID
- NCT04167722
- Acronym / sponsor ID
- EXOPRO / 19HH5065
- Conditions
- Prostate Cancer, Obesity
- Keywords
- Prostate Cancer, Obesity, Exosomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Experimental Cancer Medicine Centres
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Procedure: Robotic Radical ProstatectomyBMI > 25 |
| Lean patients | – | Procedure: Robotic Radical ProstatectomyBMI < or = 25 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obese vs lean patients
Key inclusion criteria (1 listed)
- All men undergoing radical prostatectomy at Charing Cross Hospital
Key exclusion criteria (1 listed)
- Patients unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Radical ProstatectomyRoutine NHS Radical Prostatectomy | Procedure or surgery | Lean patients, Obese patients |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Bevan, PhD principal investigator
Imperial College London
Mathias Winkler, FRCS principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Tam, MBBCh (+442075942135, j.tam18@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.