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

Launched by FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA · Mar 21, 2024

Keywords

ClinConnect Summary

The INSIDE clinical trial is looking to better understand how certain gene changes in prostate cancer can affect treatment options. This study will involve 400 men with prostate cancer, and they will be placed into three groups based on their cancer type. The first group includes men with high-risk localized prostate cancer, the second group involves those with newly diagnosed metastatic hormone-sensitive prostate cancer, and the third group consists of men whose cancer has spread and is resistant to hormone treatment.

To participate, men must be at least 18 years old and have specific types of prostate cancer with available biopsy tissue. Participants will need to agree to undergo a biopsy, especially if they're in the group with advanced cancer. Throughout the trial, participants can expect regular assessments and to learn more about how their cancer's genetic makeup affects their treatment. This study is currently recruiting participants who meet the criteria, so it's a great opportunity for those affected by prostate cancer to potentially contribute to important research.

Gender

MALE

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