Early Detection of Prostate Cancer (NCT04556916) | Clinical Trial Compass
RecruitingNot Applicable
Early Detection of Prostate Cancer
France320 participantsStarted 2021-02-19
Plain-language summary
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection.
In the first discovery period, the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls. Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score ("gold standard") of 8 or higher (ISUP 4 and higher), will be performed. The resulting biomarker candidates will then be further explored in the subsequent training and validation study (years 2 and 3) in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa and/or high-risk PCa. The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer, based on classic peripheral tumour markers, such as Prostate Health Index (PHI) and PCA3. Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project. Here, the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Patient :
* Men over 40 being suspicious of prostate cancer
* Subject with PSA ≥ 4 and designated for biopsy
* Subjects must be able to attend all scheduled visits and to comply with all trial procedures
* mpMRI done before prostate biopsy
* Subject must be covered by public health insurance
* Signed informed consent form
Inclusion Criteria Subject Control Patient patient free from prostatic disease :
* Men over 40 with no suspicion of prostate cancer
* Subject with PSA \< 2.5 and normal digital rectal examination
* Subject must be covered by public health insurance
* Signed informed consent form
Exclusion Criteria Patient :
* Subject with histologically confirmed prostate cancer
* Subject with a verified viral infection (HIV or Hepatitis)
* Subject under Finasteride treatment
* Subject under hormonal treatment (analogs, antagonists, androgenics)
* Subject with other cancer diagnosed
* Subject unable to sign consent
* Planned longer stay outside the region that prevents compliance with the visit plan
* Subject deprived of liberty, protected adults or vulnerable persons
* Urinary infection ≤ 2 months
* Subject excluding health insurance registration
* Subject refusing to perform prostate biopsy
* Subject who are in a dependency or employment with the sponsor or the investigator
Exclusion Criteria Subject Control :
* Subject with histologically confirmed prostate cancer
* Subject with a verified viral infection (HIV or Hepatitis)
* Subject under Finast…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Discovery of CTCs and tumour cell products circulating in blood (DNA, exosomes) for early PCa detection.
Timeframe: Expected duration of the recruitment of the discovery phase: 12 months