NCT06334809Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 16 Feb 2024
- Start date
- 9 Mar 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Diseases
- Prostate cancer
- NCT number
- NCT06334809
What you commit to
- Study type: Observational
- Planned participants: 400
- From 9 Mar 2023 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia IRCCS Candiolo Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| Aou San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.