NCT04556916

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
89mo left

Started Feb 2021

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Feb 2021Sep 2033

First Submitted

Initial submission to the registry

June 23, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 19, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2033

Expected
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

June 23, 2020

Last Update Submit

December 31, 2021

Conditions

Prostate Cancer

Keywords

prostate cancerliquid biopsycirculating tumour cells

Outcome Measures

Primary Outcomes (1)

  • Discovery of CTCs and tumour cell products circulating in blood (DNA, exosomes) for early PCa detection.

    Evaluate Liquid biopsy marker between the patients with histologically proven PCa and age-matched noncancer controls.

    Expected duration of the recruitment of the discovery phase: 12 months

Secondary Outcomes (3)

  • Detection duration of the recruitment of the validation study.

    Expected duration of the recruitment of the validation study: 24 months

  • Validity of blood test with the highest specificity for detection of early PCa and/or high-risk PCa.

    Expected duration of the recruitment of the validation study: 24 months

  • Validity of blood test with the highest specificity for detection of early PCa and/or high-risk PCa.

    Expected duration of the recruitment of the validation study: 24 months

Study Arms (2)

Men over 40 being suspicious of prostate cancer

EXPERIMENTAL

Per patient 49 ml of peripheral blood sample after signing consent and performing before the 1st prostate biopsy

Diagnostic Test: Blood sample

Men over 40 with no suspicion of prostate cancer

EXPERIMENTAL

Per patient 49 ml of peripheral blood sample after signing consent

Diagnostic Test: Blood sample

Interventions

Blood sampleDIAGNOSTIC_TEST

Per patient 49 ml of peripheral blood sample : * 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis; * 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation.

Men over 40 being suspicious of prostate cancerMen over 40 with no suspicion of prostate cancer

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen over 40 years
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • Subject with histologically confirmed prostate cancer
  • Subject with a verified viral infection (HIV or Hepatitis)
  • Subject under Finasteride treatment
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Catherine ALIX-PANABIERES, MCU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine ALIX-PANABIERES, MCU-PH

CONTACT

+33 4 11 75 99 31c-panabieres@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

September 21, 2020

Study Start

February 19, 2021

Primary Completion

November 15, 2023

Study Completion (Estimated)

September 15, 2033

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)