Clinical trial · Interventional
Early Detection of Prostate Cancer
Early Detection of Prostate Cancer by Liquid Biopsy
- 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)
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.
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 |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Men over 40 being suspicious of prostate cancer
- description
- Per patient 49 ml of peripheral blood sample after signing consent and performing before the 1st prostate biopsy
- interventionNames
- Diagnostic Test: Blood sample
- type
- EXPERIMENTAL
- label
- Men over 40 with no suspicion of prostate cancer
- description
- Per patient 49 ml of peripheral blood sample after signing consent
- interventionNames
- Diagnostic Test: Blood sample
Primary outcomes (1)
- measure
- Discovery of CTCs and tumour cell products circulating in blood (DNA, exosomes) for early PCa detection.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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 Finasteride treatment * 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
References
Publications (0)
Data not yet available