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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
biological samples collection and analysis
Other interventionParticipants 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
7
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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
Secondary outcomes
Biomarkers inter and intra variability
to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines.
Metabolomic and metagenomic analysis
to set-up the microbiota analysis and blood analysis quantification and determine the intra- and inter-patient variability (Group 0);
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
Sponsors and contacts
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Oncology Institute of Southern Switzerland
Lead sponsor
Clinical Trial Unit Ente Ospedaliero Cantonale
Collaborator