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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: biological samples collection and analysis

• Registration Number: NCT03408964
• Lead Sponsor: Andrea Alimonti

Brief Summary

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.

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.

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	biological samples collection and analysis	Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy
Group 0 (set-up)	biological samples collection and analysis	Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis)
Group 1	biological samples collection and analysis	Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy
Group 3	biological samples collection and analysis	Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy
Group 1a (control)	biological samples collection and analysis	Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

Oncology Institute of Southern Switzerland (IOSI); 🇨🇭 Bellinzona, Switzerland