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

Prostate Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06334809
• Study type: Observational
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: ilaria Buondonno, PhD
• Phone: +390119933393
• Email: ilaria.buondonno@ircc.it
• Status: Recruiting
• Start date: March 9, 2023
• Completion date: December 31, 2027