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)

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, Italy

AOU San Luigi Gonzaga

Orbassano, Turin, Italy

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NCT06334809


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