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

Prostate Cancer Clinical Trial

Official title:

An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03408964
• Other study ID #: IOSI-IOR-002
• Status: Recruiting
• Start date: December 15, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Oncology Institute of Southern Switzerland
• Contact: Andrea Alimonti, Prof.
• Phone: +41 (0)91 8210080
• Email: andrea.alimonti[@]ior.iosi.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona

Sponsors (2)

Lead Sponsor	Collaborator
Andrea Alimonti	Clinical Trial Unit Ente Ospedaliero Cantonale

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Biomarkers inter and intra variability	to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines.	3 years
Secondary	Metabolomic and metagenomic analysis	to set-up the microbiota analysis and blood analysis quantification and determine the intra- and inter-patient variability (Group 0);	3 years
Secondary	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