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| Name | Class |
|---|---|
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 0 (set-up) | Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis) |
| |
| Group 1a (control) | Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer |
| |
| Group 1 | Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy |
| |
| Group 2 | Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy |
| |
| Group 3 | Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy |
| |
| Group Exo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological samples collection and analysis | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers inter and intra variability | to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines. | 3 years |
| Metabolomic and metagenomic analysis | to set-up the microbiota analysis and blood analysis quantification and determine the intra- and inter-patient variability (Group 0); |
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Inclusion Criteria:
General inclusion criteria (for entering all groups)
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 exclusion criteria (for entering all groups)
Exclusion criterion only for entering Group 0
• No antibiotic treatments in the previous 2 months before enrollment
Exclusion criteria only for entering Group 1
Exclusion criteria only for entering Group 2
Exclusion criterion only for entering Group 3
• No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)
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Patients with prostate adenocarcinoma at different stages of disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Pereira Mestre, MD | Contact | +41 (0)91 811 8446 | ricardo.pereiramestre@eoc.ch | |
| Andrea Alimonti, Prof. | Contact | +41 (0)91 8210080 | andrea.alimonti@ior.iosi.ch |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Pereira Mestre, MD | Oncology Institute of Southern Switzerland (IOSI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland (IOSI) | Recruiting | Bellinzona | 6500 | Switzerland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Blood sample
Patients with a known or suspected diagnosis of PC or at any stage of the disease and irrespective of the treatment undergoing an imaging investigation. |
|
| Group Bio | Patients with a known or suspected diagnosis of PC at any stage of the disease and irrespective of the treatment undergoing a tumour sampling. |
|
| 3 years |
| 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 | 3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |