The Prostate Liquid Study (PLiS)
PLiS
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
1 other identifier
observational
300
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedMarch 26, 2020
March 1, 2020
1.4 years
September 13, 2019
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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.
18 Months
Threshold
Optimal threshold for the ChEC-S diagnostic score
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
18 Months
Secondary Outcomes (4)
Proportion of significance
18 Months
Value
18 Months
Hypogonadism Impact
18 Months
Resource
18 Months
Interventions
Patients will be asked to donate a semen sample which will be analysed and compared with their eventual diagnosis.
Eligibility Criteria
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.
You may qualify if:
- \- 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
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University College Hospital
London, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2019
First Posted
September 25, 2019
Study Start
October 1, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
March 26, 2020
Record last verified: 2020-03