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

November 14, 2025 updated by: Oncology Institute of Southern Switzerland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • Oncology Institute of Southern Switzerland (IOSI)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with prostate adenocarcinoma at different stages of disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 0 (set-up)
Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis)
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
Group 1a (control)
Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer
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
Group 1
Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy
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
Group 2
Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy
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
Group 3
Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy
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
Group Exo
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biomarkers inter and intra variability
Time Frame: 3 years
to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines.
3 years
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 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oncology Institute of Southern Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Trial Unit Ente Ospedaliero Cantonale

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ricardo Pereira Mestre, MD, Oncology Institute of Southern Switzerland (IOSI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IOSI-IOR-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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