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Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
RECRUITINGSponsored by Oncology Institute of Southern Switzerland
Actively Recruiting
SponsorOncology Institute of Southern Switzerland
Started2017-12-15
Est. completion2028-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03408964
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
Age: 18 Years+Sex: MALEHealthy volunteers accepted
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)
Conditions2
CancerProstate Cancer
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Actively Recruiting
SponsorOncology Institute of Southern Switzerland
Started2017-12-15
Est. completion2028-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03408964