An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Switzerland
Oncology Institute of Southern Switzerland (IOSI)
RECRUITING
Bellinzona
Contact Information
Primary
Ricardo Pereira Mestre, MD
ricardo.pereiramestre@eoc.ch
+41 (0)91 811 8446
Backup
Andrea Alimonti, Prof.
andrea.alimonti@ior.iosi.ch
+41 (0)91 8210080
Time Frame
Start Date: 2017-12-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 600
Treatments
Group 0 (set-up)
Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis)
Group 1a (control)
Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer
Group 1
Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy
Group 2
Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy
Group 3
Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Trial Unit Ente Ospedaliero Cantonale
Leads: Oncology Institute of Southern Switzerland