Screening men with prostate cancer for DNA repair gene changes
Looks for DNA repair gene changes in adults with prostate cancer in 3 groups.
Plain-language title generated from the registry record
Registry title: INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Key facts
- Where
- Candiolo and Orbassano, ItalySee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer in one of three groups: high-risk cancer that has not spread, cancer that has spread and still responds to hormone treatment, or cancer that has spread and stopped responding to hormone treatment.
- Age
- Older than 18 years.
- Sex
- Men only.
- Disease stage
- Cohort A: high-risk prostate cancer that has not spread (stage above cT3, or PSA above 20 ng/mL, or cancer growing beyond the prostate capsule or into the seminal vesicles on MRI). Cohort B: cancer that has spread at first diagnosis and is hormone sensitive. Cohort C: cancer that has spread and is getting worse during standard treatment, despite hormone-lowering therapy.
- Earlier treatment
- Cohort A: people who have had or are having treatment meant to remove the cancer (prostate surgery or radical radiotherapy) but have not started the follow-up pathway. Cohort B: no standard treatment yet, or started no more than 3 months ago. Cohort C: the cancer is getting worse on a standard treatment.
- Biomarker or test result
- Tissue from a diagnostic biopsy or prostate surgery must be available. Cohort B and C also need tissue from a spread site where possible; cohort C must accept a biopsy of a spread site.
Main reasons for not taking part
- People not willing to follow the study's procedures
Read by machine on 12 November 2026.
Where in Italy
- Fondazione del Piemonte per l'Oncologia IRCCS CandioloCandiolo, ItalyContact: Pasquale Rescigno, MDTaking people
- Aou San Luigi GonzagaOrbassano, ItalyContact: Francesco Porpiglia, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione del Piemonte per l'Oncologia
- Trial code
- NCT06334809
- Record updated
- 12 June 2025
- Original description
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;Read full original descriptionShow less
Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
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.
Inclusion: 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.
Exclusion: Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.