Detecting prostate cancer early using blood tests
Early Detection of Prostate Cancer by Liquid Biopsy
This study is testing whether blood tests can help find prostate cancer earlier in patients who might have it by looking for specific markers in their blood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 4 sites (Montpellier and 3 other locations) |
| Trial ID | NCT04556916 on ClinicalTrials.gov |
What this trial studies
This study focuses on the early detection of prostate cancer by analyzing circulating blood-based biomarkers, specifically circulating tumor cells (CTCs) and tumor cell products. Patients suspected of having prostate cancer will provide blood samples before undergoing a biopsy, allowing researchers to assess which liquid biopsy markers can best differentiate between those with prostate cancer and age-matched controls. The study aims to identify high-risk patients with aggressive tumors and validate the effectiveness of these biomarkers compared to current standard detection methods.
Who should consider this trial
Good fit: Ideal candidates include men over 40 who are suspected of having prostate cancer and are scheduled for a biopsy.
Not a fit: Patients with histologically confirmed prostate cancer or those undergoing certain treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and less invasive method for early detection of prostate cancer.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach is still being validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier and 3 other locations
- CHU Montpellier - Département d'urologie et transplantation rénale — Montpellier, France (Recruiting)
- CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines — Montpellier, France (Active_not_recruiting)
- Clinique Beau Soleil - Service d'urologie — Montpellier, France (Recruiting)
- CHU de Nîmes - Service Urologie Andrologie Sexologie — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Catherine ALIX-PANABIERES, MCU-PH — University Hospital, Montpellier
- Study coordinator: Catherine ALIX-PANABIERES, MCU-PH
- Email: c-panabieres@chu-montpellier.fr
- Phone: +33 4 11 75 99 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.