NCT06334809

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Timeline

• Start date: 2023-03-09
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-03-28
• Last updated: 2025-06-12

Locations

2 sites across 1 country: Italy