About this trial
400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI;
Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);
Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Ability to understand and consent to informed consent;
Patient must be compliant with receiving a biopsy of the metastatic site (cohort C) and with FU assessments schedule
Disqualifiers
None
Trial population
Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI; Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC); Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number, type and frequency of DDR and MMR germline/somatic alterations
Evaluation of the frequency, number and type of DDR and MMR germline/somatic alterations in the study population
Changes in PSA levels in the 3 cohorts
Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment
Secondary outcomes
Number of patient-derived preclinical models
Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs)
Sponsors and contacts
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