INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Recruiting · NCT06334809 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione del Piemonte per l'Oncologia
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo - Candiolo, Turin, Italy
- AOU San Luigi Gonzaga - Orbassano, Turin, Italy