Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
Recruiting · NCT03408964 · Observational (researchers observe without assigning treatment) · Lead sponsor: Oncology Institute of Southern Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
biological samples collection and analysis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
1 location listed.
- Oncology Institute of Southern Switzerland (IOSI) - Bellinzona, Switzerland