Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients

NCT03408964 | Recruiting

• 1 other identifier: IOSI-IOR-002
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Biomarkers value in the response to therapy

  To assess the value of MDSCs, NLR, cytokines as biomarkers of clinical outcome at different stages of disease and their correlation with PSA, the marker usually used for PC

  3 years

Secondary Outcomes (3)

• Biomarkers inter and intra variability

  3 years

• Metabolomic and metagenomic analysis

  3 years

• Metabolomic and metagenomic analysis

  3 years

Study Arms (7)

Group 0 (set-up)

Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis)

Other: biological samples collection and analysis

Group 1a (control)

Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer

Other: biological samples collection and analysis

Group 1

Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy

Other: biological samples collection and analysis

Group 2

Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy

Other: biological samples collection and analysis

Group 3

Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy

Other: biological samples collection and analysis

Group Exo

Patients with a known or suspected diagnosis of PC or at any stage of the disease and irrespective of the treatment undergoing an imaging investigation.

Other: biological samples collection and analysis

Group Bio

Patients with a known or suspected diagnosis of PC at any stage of the disease and irrespective of the treatment undergoing a tumour sampling.

Other: biological samples collection and analysis

Interventions

biological samples collection and analysis OTHER

Participants to the study will be assigned to 4 cohorts according to the stage of disease and planned antitumor treatment at time of study entry; they will be followed up and sampled according to a defined time schedule

Group 0 (set-up); Group 1; Group 1a (control); Group 2; Group 3; Group Bio; Group Exo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prostate adenocarcinoma at different stages of disease

You may qualify if:

• 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
• Patients with a known diagnosis of CSPC or CRPC
• Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer

You may not qualify if:

• 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
• No antibiotic treatments in the previous 2 months before enrollment
• Previous radical surgery and / or radical radiotherapy
• Previous hormonal treatments
• 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
• No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ricardo Pereira Mestre, MD

  Oncology Institute of Southern Switzerland (IOSI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Pereira Mestre, MD

CONTACT

+41 (0)91 811 8446; ricardo.pereiramestre@eoc.ch

Andrea Alimonti, Prof.

CONTACT

+41 (0)91 8210080; andrea.alimonti@ior.iosi.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 24, 2018
• Study Start: December 15, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)