Prostate CancerPLiSNCT04102904
The Prostate Liquid Study (PLiS)
An observational study of Prostate Cancer, run by University College, London at 2 sites in United Kingdom.
Trial summary
A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Observational
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2019to Mar 2021
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men over the age of 40 who have been referred for secondary care due to suspicion of prostate cancer who are able to have an MRI scan and produce a semen sample.
Who may be able to join
- - Men over 40 years old with suspected prostate cancer who have been referred to a secondary care
- - Men able to produce a semen sample
- - Men able to have a prostate mpMRI
- - Men who have given their written informed consent
Who cannot join
- - Previous history of prostate biopsy
- - Contraindication to MRI
- - Previous history of prostate surgery
- - Treatment with 5-alpha-reductase inhibitors at time of registration or during the prior 6 months
- - Evidence of urinary tract infection or history of acute prostatitis within the last month
- - Androgen replacement therapy within the last 3 months
- - Any other medical condition precluding standard diagnostic workup and collection of semen samples.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
University College Hospital
London
Charlie Mizon, charlie.mizon@nhs.net
- Recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
Denise Archer, denise.archer@nnuh.nhs.uk
About this study
Official title: A Multi-centre Validation Cohort Study Evaluating the Chemical Elements Content in Semen and Expressed Prostatic Secretions in the Diagnosis and Characterisation of Prostate Cancer, in Men Identified as Having a Risk of Prostate Cancer
A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.
Read the detailed description
A biomarker is a molecular substance that is an indicator of a biological condition. Cambridge Oncometrix believe that a semen biomarker may be able to predict the presence of prostate cancer. This study will allow work to be carried out on semen samples donated by men who have been identified by their GPs as having a risk of prostate cancer. Normally, GPs refer men with symptoms or a raised PSA to hospital to have an MRI scan and a biopsy.
The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided.
In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.
- Conditions
- Prostate Cancer
- Being tested
- Observational
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Patients will be asked to donate a semen sample which will be analysed and compared with their eventual diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Metrics of the ChEC-S test
Sensitivity, specificity, negative and positive predictive values, and reciever operating characteristics (area under the curve) in the participants with a high risk of prostate cancer using mpMRI as a clinical reference standard.
Measured: 18 Months
Threshold
Optimal threshold for the ChEC-S diagnostic score
Measured: 18 Months
Proportion
Proportion of men who could safely avoid an MRI targeted biopsy as determined by specificity and negative predictive values of the ChEC-S test at the optimal ChEC-S test cut-off levels
Measured: 18 Months
Secondary outcomes (4)
Proportion of significance
Proportion of men correctly identified of ChEC-S test to have clinically significant prostate cancer
Measured: 18 Months
Value
Value of the ChEC-S test as a prognostic marker of clinically significant prostate cancer (a positive predictive value). Evaluation of the prognostic power of the chemical elements as biomarkers of aggressive prostate cancer using Gleason score as clinical reference standard.
Measured: 18 Months
Hypogonadism Impact
The impact of hypogonadism on the ChEC-S score
Measured: 18 Months
Resource
Resource use and costs for further economic evaluation
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (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 University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102904
- Sponsor's protocol ID
- 18/0526
- Acronym
- PLiS
- Status last verified
- Mar 2020
- First submitted
- 13 Sep 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Validation Cohort Study Evaluating the Chemical Elements Content in Semen and Expressed Prostatic Secretions in the Diagnosis and Characterisation of Prostate Cancer, in Men Identified as Having a Risk of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04102904
- Acronym / sponsor ID
- PLiS / 18/0526
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 25 Sep 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.
A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.
Detailed description
A biomarker is a molecular substance that is an indicator of a biological condition. Cambridge Oncometrix believe that a semen biomarker may be able to predict the presence of prostate cancer. This study will allow work to be carried out on semen samples donated by men who have been identified by their GPs as having a risk of prostate cancer. Normally, GPs refer men with symptoms or a raised PSA to hospital to have an MRI scan and a biopsy.
The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided.
In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men over the age of 40 who have been referred for secondary care due to suspicion of prostate cancer who are able to have an MRI scan and produce a semen sample.
Key inclusion criteria (4 listed)
- - Men over 40 years old with suspected prostate cancer who have been referred to a secondary care
- - Men able to produce a semen sample
- - Men able to have a prostate mpMRI
- - Men who have given their written informed consent
Key exclusion criteria (7 listed)
- - Previous history of prostate biopsy
- - Contraindication to MRI
- - Previous history of prostate surgery
- - Treatment with 5-alpha-reductase inhibitors at time of registration or during the prior 6 months
- - Evidence of urinary tract infection or history of acute prostatitis within the last month
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 |
|---|---|---|
| ObservationalPatients will be asked to donate a semen sample which will be analysed and compared with their eventual diagnosis. | Other | – |
Primary outcome
Metrics of the ChEC-S test
Time frame: 18 Months
Sensitivity, specificity, negative and positive predictive values, and reciever operating characteristics (area under the curve) in the participants with a high risk of prostate cancer using mpMRI as a clinical reference standard.
Threshold
Time frame: 18 Months
Optimal threshold for the ChEC-S diagnostic score
Proportion
Time frame: 18 Months
Proportion of men who could safely avoid an MRI targeted biopsy as determined by specificity and negative predictive values of the ChEC-S test at the optimal ChEC-S test cut-off levels
4 secondary outcomes
Proportion of significance
Time frame: 18 Months
Value
Time frame: 18 Months
Hypogonadism Impact
Time frame: 18 Months
Resource
Time frame: 18 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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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.
2 sites 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, run by University College, London at 2 sites 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 4 inclusion and 7 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Charlie Mizon (02076799063, charlie.mizon@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metrics of the ChEC-S test (time frame: 18 Months). The study lists 3 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 26 Mar 2020.