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

NCT ID: NCT06334809

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2027-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A:patients with high risk localized prostate cancer

Cohort A:150 patients with high risk localized prostate cancer (defined as >cT3 or PSA > 20 ng/mL or presence of ECE or SVIat mpMRI), with tissue available from diagnostic biopsy/prostatectomy undergoing or who underwent curative treatment (prostatectomy/radical radiotherapy) but have not started a FU pathway.

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

No interventions assigned to this group

Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC)

Cohort B: 100 patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. Patients must either have not started a standard treatment or have started for not longer than 3 months;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

No interventions assigned to this group

Cohort C:Patients with metastatic castration resistant prostate cancer (mCRPC) progressing

Cohort C:100-150 patients with metastatic castration resistant prostate cancer tissue (mCRPC) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary.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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Diagnosis of prostate cancer as indicated below:

Cohort A: patients with high risk localized prostate cancer (defined as >cT3 or PSA > 20 ng/mL or presence of ECE or SVIat mpMRI), with tissue available from diagnostic biopsy/ prostatectomy undergoing or who underwent curative treatment (prostatectomy/ radical radiotherapy) but have not started a FU pathway.

Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. Patients must either have not started a standard treatment or have started for not longer than 3 months.

Cohort C: patients with metastatic castration resistant prostate cancer tissue (mCRPC) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pasquale Rescigno, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Sabrina Arena, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Locations

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, Italy

Site Status: RECRUITING

AOU San Luigi Gonzaga

Orbassano, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ilaria Buondonno, PhD

Role: CONTACT

ilaria.buondonno@ircc.it

+390119933393

Marco Asioli

Role: CONTACT

ufficio.trials@ircc.it

+390119933463

Facility Contacts

Pasquale Rescigno, MD

Role: primary

pasquale.rescigno@ircc.it

Ilaria Buondonno, PhD

Role: backup

ilaria.buondonno@ircc.it

+390119933393

Francesco Porpiglia, MD

Role: primary

Other Identifiers

028FPO22

Identifier Type: -

Identifier Source: org_study_id