Spots Global Cancer Trial Database for INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations

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Trial Identification

Brief Title: INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations

Official Title: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations

Study ID: NCT06334809

Conditions

Prostate Cancer

Interventions

Study Description

Brief Summary: 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.

Detailed Description: In this study 150 patients will be enrolled in cohort A, 100 patients in cohort B and 100-150 patients in Cohort C. Considering the known frequency of DDR and MMR germline/somatic alterations, it is expected to see: * 15-23 patients with germline/somatic DDR defects and 5-7 MMR alterations in cohort A; * 20-25 patients with germline/somatic DDR defects and 5-7 MMR alterations in cohort B; * 25-35 patients with germline/somatic DDR defects and 7-10 MMR alterations in cohort C. Patients within Cohort A will be followed up with PSA every 3 months for 3 years and early scans. They will also receive a blood sample for ctDNA/CTC before (when feasible) and after radical treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression; Patients within Cohort B will be followed up with PSA and scans every 3 months. They will also receive a blood sample before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression. Patients within Cohort C will be followed up with PSA monthly and scans every 3 month. They will also receive a blood sample for ctDNA/CTC before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression.