The Prostate Liquid Study (PLiS)

Prostate Cancer Clinical Trial

— PLiS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102904
• Other study ID #: 18/0526
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: March 2021

Study information

• Verified date: March 2020
• Source: University College, London
• Contact: Charlie Mizon
• Phone: 02076799063
• Email: charlie.mizon[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Observational
Patients will be asked to donate a semen sample which will be analysed and compared with their eventual diagnosis.

Locations

Country	Name	City	State
United Kingdom	University College Hospital	London
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Threshold	Optimal threshold for the ChEC-S diagnostic score	18 Months
Primary	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	Proportion of significance	Proportion of men correctly identified of ChEC-S test to have clinically significant prostate cancer	18 Months
Secondary	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.	18 Months
Secondary	Hypogonadism Impact	The impact of hypogonadism on the ChEC-S score	18 Months
Secondary	Resource	Resource use and costs for further economic evaluation	18 Months