Status:
RECRUITING
Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
Lead Sponsor:
Oncology Institute of Southern Switzerland
Collaborating Sponsors:
Clinical Trial Unit Ente Ospedaliero Cantonale
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief 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 collec...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03408964
Start Date
December 15 2017
End Date
December 31 2028
Last Update
November 18 2025
Active Locations (1)
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1
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500