RecruitingNCT06334809
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
Sponsor
Fondazione del Piemonte per l'Oncologia
Enrollment
400 participants
Start Date
Mar 9, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria7
- 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
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06334809
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