Prostate CancerNCT03408964
Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
An observational study of Prostate Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- biological samples collection and analysis
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2017to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prostate adenocarcinoma at different stages of disease
Who may be able to join
- 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
- Patients with a known diagnosis of CSPC or CRPC
- Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer
Who cannot join
- 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
Show all 13Show fewer
- Diagnosis of second tumor in the previous 5 years
- No antibiotic treatments in the previous 2 months before enrollment
- Previous radical surgery and / or radical radiotherapy
- Previous hormonal treatments
- 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
- No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, 6500
Pereira Mestre Ricardo, MD, +41 (0)91 811 84 46, ricardo.pereiramestre@eoc.ch
Luigi Tortola, PhD, +41 (0)91 811 96 68, luigi.tortola@eoc.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- biological samples collection and analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samples collection and analysisOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 0 (set-up) | Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis) Receives: Other: biological samples collection and analysis | |
| Group 1a (control) | Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer Receives: Other: biological samples collection and analysis | |
| Group 1 | Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy Receives: Other: biological samples collection and analysis | |
| Group 2 | Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy Receives: Other: biological samples collection and analysis | |
| Group 3 | Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy Receives: Other: biological samples collection and analysis | |
| 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. Receives: Other: biological samples collection and analysis | |
| 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. Receives: Other: biological samples collection and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (3)
Biomarkers inter and intra variability
to assess the inter- and intra-variability of the value of MDSCs, NLR and cytochines.
Measured: 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);
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start15 Dec 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor
- Investigators
- Ricardo Pereira Mestre, MD, Principal investigator, Oncology Institute of Southern Switzerland (IOSI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408964
- Sponsor's protocol ID
- IOSI-IOR-002
- Status last verified
- Nov 2025
- First submitted
- 11 Jan 2018
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study
- ClinicalTrials.gov ID
- NCT03408964
- Acronym / sponsor ID
- IOSI-IOR-002
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 0 (set-up) | – | Other: biological samples collection and analysisPatients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis) |
| Group 1a (control) | – | Other: biological samples collection and analysisPatients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer |
| Group 1 | – | Other: biological samples collection and analysisPatients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy |
| Group 2 | – | Other: biological samples collection and analysisPatients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy |
| Group 3 | – | Other: biological samples collection and analysisPatients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy |
| Group Exo | – | Other: biological samples collection and analysisPatients 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 | – | Other: biological samples collection and analysisPatients with a known or suspected diagnosis of PC at any stage of the disease and irrespective of the treatment undergoing a tumour sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate adenocarcinoma at different stages of disease
Key inclusion criteria (6 listed)
- 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
- Patients with a known diagnosis of CSPC or CRPC
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samples collection and analysisParticipants 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 | Other | Group 0 (set-up), Group 1, Group 1a (control), Group 2, Group 3, Group Bio, Group Exo |
Primary outcome
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 secondary outcomes
Biomarkers inter and intra variability
Time frame: 3 years
Metabolomic and metagenomic analysis
Time frame: 3 years
Metabolomic and metagenomic analysis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo Pereira Mestre, MD principal investigator
Oncology Institute of Southern Switzerland (IOSI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Pereira Mestre, MD (+41 (0)91 811 8446, ricardo.pereiramestre@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers value in the response to therapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.