Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorOncology Institute of Southern Switzerland

About this trial

Participants to the study will be assigned to 7 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.

In all patients, 12 ml of blood sample will be collected in EDTA tube for analysis of biological biomarkers in different time points.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated

Written Informed Consent

Disqualifiers

Active infection requiring treatment

Decrease of general condition

Concomitant severe comorbities

Difficult socioeconomic conditions making regular follow up unfeasible.

Trial population

Patients with prostate adenocarcinoma at different stages of disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • biological samples collection and analysis

    Other intervention

    Participants to the study will be assigned to 4 cohorts according to the stage of disease and planned antitumor treatment at time of study entry; they will be followed up and sampled according to a defined time schedule

Treatment groups

600 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Group 0 (set-up)1 intervention
Group B: Group 1a (control)1 intervention
Group C: Group 11 intervention
Group D: Group 21 intervention
Group E: Group 31 intervention
Group F: Group Exo1 intervention
Group G: Group Bio1 intervention

Trial outcomes

Primary outcomes

1

Biomarkers value in the response to therapy

To assess the value of MDSCs, NLR, cytokines as biomarkers of clinical outcome at different stages of disease and their correlation with PSA, the marker usually used for PC

Time frame
3 years

Secondary outcomes

1

Biomarkers inter and intra variability

to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines.

Time frame
3 years
2

Metabolomic and metagenomic analysis

to set-up the microbiota analysis and blood analysis quantification and determine the intra- and inter-patient variability (Group 0);

Time frame
3 years
3

Metabolomic and metagenomic analysis

to assess the diversity and the composition of the intestinal microbiota and its blood metabolites in PC patients in castration-sensitive (Group 2) and castration-resistant (Group 3) phase

Time frame
3 years

Other outcomes

Sponsors and contacts

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Oncology Institute of Southern Switzerland

Lead sponsor

Clinical Trial Unit Ente Ospedaliero Cantonale

Collaborator