Clinical trial · Observational
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
NCT03408964CI-TRIAL-00097353recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological samples collection and analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- label
- Group 0 (set-up)
- description
- Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis)
- interventionNames
- Other: biological samples collection and analysis
- label
- Group 1a (control)
- description
- Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer
- interventionNames
- Other: biological samples collection and analysis
- label
- Group 1
- description
- Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy
- interventionNames
- Other: biological samples collection and analysis
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.