Identifying genomic screening pathways in prostate cancer patients with DNA repair alterations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enroll 400 prostate cancer patients and categorize them into three cohorts based on their disease stage and treatment history. Cohort A includes patients with high-risk localized prostate cancer, Cohort B consists of those with de novo metastatic hormone-sensitive prostate cancer, and Cohort C includes patients with metastatic castration-resistant prostate cancer. Each cohort will undergo regular follow-ups involving PSA tests and blood samples for ctDNA/CTC analysis to monitor disease progression and genomic alterations. The study seeks to identify the frequency of DNA damage response (DDR) and mismatch repair (MMR) alterations across these patient groups.

Why it matters

Who can join: the full rules

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's running

• Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
  Candiolo, Turin, Italy Recruiting
• AOU San Luigi Gonzaga
  Orbassano, Turin, Italy Recruiting

Study contacts

• Principal investigator: Pasquale Rescigno, MD — Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
• Study coordinator: ilaria Buondonno, PhD
• Email: ilaria.buondonno@ircc.it
• Phone: +390119933393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.