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INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
RECRUITINGSponsored by Fondazione del Piemonte per l'Oncologia
Actively Recruiting
SponsorFondazione del Piemonte per l'Oncologia
Started2023-03-09
Est. completion2026-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06334809
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
Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.
Conditions2
CancerProstate Cancer
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Actively Recruiting
SponsorFondazione del Piemonte per l'Oncologia
Started2023-03-09
Est. completion2026-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06334809