Early Detection of Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sample

    Diagnostic 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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Men over 40 being suspicious of prostate cancerExperimental treatment 1 intervention
Group B: Men over 40 with no suspicion of prostate cancerExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Detection duration of the recruitment of the validation study.

The most marker(s) assay(s) will be further explored in the subsequent training and validation study in order to obtain the blood test to detect early prostate cancer in patients with elevated serum PSA.

Time frame
Expected duration of the recruitment of the validation study: 24 months
2

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

Combination of complementary circulating biomarkers as liquid biopsy of cancer (CTCs, circulating tumor DNA \& exosomes).

Time frame
Expected duration of the recruitment of the validation study: 24 months
3

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

Measure the prognostic relevance of candidate biomarkers

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

Other outcomes

Sponsors and contacts

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