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

Recruiting now

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06334809

Run by

Fondazione del Piemonte per l'Oncologia

People needed

400

Starts

2023-03-09

Expected to finish

2027-12-31

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.

Where it is running

• Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo — Candiolo, Turin, Italy (enrolling)
• AOU San Luigi Gonzaga — Orbassano, Turin, Italy (enrolling)

Full record on ClinicalTrials.gov

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