Prostate Cancer
Conditions
Brief summary
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.
Detailed description
Participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry. Group 0 (set-up): blood sampling and rectal swab will be collected at a single time-point during the PC treatment. No follow-up is required. Group 1a (control): the first blood sampling will be performed within 4 weeks since the negative biopsy; subsequent samplings will be done according to a schedule comparable to that of Group 1 up to 1 year or evidence of tumor, whichever occurs first. Group 1, Group 2 and Group 3: the first blood sampling will be performed before radical treatment or HT start or CT start, on the basis of the planned antitumor therapy; subsequent sampling will be done after radical intervention at 4 weeks (only for Group 1) and then every 3 months (or more frequently if clinically indicated), up to 3 years or evidence of tumor recurrence/progression (radiological or biochemical), whichever occurs first. At the time of recurrence/progression, patients of Group 1 could become part and could be followed as per Group 2, and patients of Group 2 could become part and could be followed as per Group 3. Group Exo and Group Bio: blood sampling will be performed at a single time-point during the PC treatment. No follow-up is required.
Interventions
OTHERbiological samples collection and analysis
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
Sponsors
Clinical Trial Unit Ente Ospedaliero Cantonale
Oncology Institute of Southern Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General inclusion criteria (for entering all groups) * 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 Inclusion criterion only for entering Group 0 • Patients with a known diagnosis of CSPC or CRPC Inclusion criterion only for entering Group 1a • Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers value in the response to therapy | 3 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers inter and intra variability | 3 years | to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines. |
| Metabolomic and metagenomic analysis | 3 years | to set-up the microbiota analysis and blood analysis quantification and determine the intra- and inter-patient variability (Group 0); |
Countries
Switzerland
Contacts
Primary ContactRicardo Pereira Mestre, MD
Backup ContactAndrea Alimonti, Prof.
Outcome results
None listed