NCT03408964Recruiting
Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 11 Jan 2018
- Start date
- 15 Dec 2017
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Diseases
- Prostate cancer
- NCT number
- NCT03408964
What you commit to
- Study type: Observational
- Planned participants: 600
- From 15 Dec 2017 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant severe comorbities
- 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
- 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
- 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)
Other illness
- Active infection requiring treatment
- Decrease of general condition
- Difficult socioeconomic conditions making regular follow up unfeasible.
Other
- General exclusion criteria (for entering all groups)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Institute of Southern Switzerland (IOSI) Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.