JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03408964

Studienbeginn:
Dezember 2017

Letztes Update:
21.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Andrea Alimonti

Collaborator:
Clinical Trial Unit Ente Ospedaliero Cantonale

Studienleiter

Andrea Alimonti, Prof.
Study Director
Institute of Oncology Research (IOR)

Kontakt

Andrea Alimonti, Prof.
Kontakt:
Phone: +41 (0)91 8210080
E-Mail: andrea.alimonti@ior.iosi.ch» Kontaktdaten anzeigen

Ricardo Pereira Mestre, MD
Kontakt:
Phone: +41 (0)91 811 8446
E-Mail: ricardo.pereiramestre@eoc.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Oncology Institute of Southern Switzerland (IOSI)
6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Pereira Mestre Ricardo, MD
Phone: +41 (0)91 811 84 46
E-Mail: ricardo.pereiramestre@eoc.ch

Barbara Marongiu
Phone: +41 (0)91 811 9120
E-Mail: barbara.marongiu@eoc.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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 exclusion criteria (for entering all groups)

- Active infection requiring treatment

- Decrease of general condition

- Concomitant severe comorbities

- Difficult socioeconomic conditions making regular follow up unfeasible.

- Need of concomitant steroids at study entry and during the study

- Diagnosis of second tumor in the previous 5 years

Exclusion criterion only for entering Group 0

• No antibiotic treatments in the previous 2 months before enrollment

Exclusion criteria only for entering Group 1

- Previous radical surgery and / or radical radiotherapy

- Previous hormonal treatments

Exclusion criteria only for entering Group 2

- No antibiotic treatments in the previous 2 months before enrollment (only in patients

enrolling also for metagenomics and metabolomics)

- Previous hormonal treatments for advanced disease

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)

Studien-Rationale

Primary outcome:

1. Biomarkers value in the response to therapy (Time Frame - 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 outcome:

1. Biomarkers inter and intra variability (Time Frame - 3 years):
to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines.

2. Metabolomic and metagenomic analysis (Time Frame - 3 years):
to set-up the microbiota analysis and blood analysis quantification and determine the intra- and inter-patient variability (Group 0);

3. Metabolomic and metagenomic analysis (Time Frame - 3 years):
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

Studien-Arme

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

Geprüfte Regime

biological 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

Quelle: ClinicalTrials.gov

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