Clinical trial · Observational
The Prostate Liquid Study (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
NCT04102904CI-TRIAL-00044263PLiSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Metrics of the ChEC-S test
- timeFrame
- 18 Months
- description
- 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.
- measure
- Threshold
- timeFrame
- 18 Months
- description
- Optimal threshold for the ChEC-S diagnostic score
- measure
- Proportion
- timeFrame
- 18 Months
- description
- 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
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. \- Men over 40 years old with suspected prostate cancer who have been referred to a secondary care 2. \- Men able to produce a semen sample 3. \- Men able to have a prostate mpMRI 4. \- Men who have given their written informed consent Exclusion Criteria: 1. \- Previous history of prostate biopsy 2. \- Contraindication to MRI 3. \- Previous history of prostate surgery 4. \- Treatment with 5-alpha-reductase inhibitors at time of registration or during the prior 6 months 5. \- Evidence of urinary tract infection or history of acute prostatitis within the last month 6. \- Androgen replacement therapy within the last 3 months 7. \- Any other medical condition precluding standard diagnostic workup and collection of semen samples.
References
Publications (0)
Data not yet available
No reference posted for this study.