NCT03408964 Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
| NCT ID | NCT03408964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oncology Institute of Southern Switzerland |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2017-12-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2017-12-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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)
Contact & Investigator
Ricardo Pereira Mestre, MD
PRINCIPAL INVESTIGATOR
Oncology Institute of Southern Switzerland (IOSI)
Frequently Asked Questions
Who can join the NCT03408964 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03408964 currently recruiting?
Yes, NCT03408964 is actively recruiting participants. Contact the research team at ricardo.pereiramestre@eoc.ch for enrollment information.
Where is the NCT03408964 trial being conducted?
This trial is being conducted at Bellinzona, Switzerland.
Who is sponsoring the NCT03408964 clinical trial?
NCT03408964 is sponsored by Oncology Institute of Southern Switzerland. The principal investigator is Ricardo Pereira Mestre, MD at Oncology Institute of Southern Switzerland (IOSI). The trial plans to enroll 600 participants.
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