NCT03408964

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Oncology Institute of Southern Switzerland · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 be collected at a single time-point during the PC treatment. No follow-up is required. Group 1a (control): the first blood sampling will be performed within 4 weeks since the negative biopsy; subsequent samplings will be done according to a schedule comparable to that of Group 1 up to 1 year or evidence of tumor, whichever occurs first. Group 1, Group 2 and Group 3: the first blood sampling will be performed before radical treatment or HT start or CT start, on the basis of the planned antitumor therapy; subsequent sampling will be done after radical intervention at 4 weeks (only for Group 1) and then every 3 months (or more frequently if clinically indicated), up to 3 years or evidence of tumor recurrence/progression (radiological or biochemical), whichever occurs first. At the time of recurrence/progression, patients of Group 1 could become part and could be followed as per Group 2, and patients of Group 2 could become part and could be followed as per Group 3. Group Exo and Group Bio: blood sampling will be performed at a single time-point during the PC treatment. No follow-up is required.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	biological samples collection and analysis	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

Timeline

• Start date: 2017-12-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2018-01-24
• Last updated: 2025-11-18

Locations

1 site across 1 country: Switzerland