NCT03408964Recruiting
Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
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.
Eligibility criteria
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)
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland
- Sponsor
- Oncology Institute of Southern Switzerland(Other)
- Protocol no.
- IOSI-IOR-002
- Conditions
- Prostate Cancer
- Interventions
- Other
Treatments studied
- biological samples collection and analysis
Collaborators
Clinical Trial Unit Ente Ospedaliero Cantonale
Locations · 1
- Bellinzona, SwitzerlandOncology Institute of Southern Switzerland (IOSI)Recruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: November 18, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.