Identifying genomic screening pathways in prostate cancer patients with DNA repair alterations
Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
This study is trying to see how common certain DNA changes are in different groups of prostate cancer patients to help understand their disease better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 2 sites (Candiolo, Turin and 1 other locations) |
| Trial ID | NCT06334809 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult males over 18 years diagnosed with high-risk localized, metastatic hormone-sensitive, or metastatic castration-resistant prostate cancer.
Not a fit: Patients with prostate cancer who do not have available tissue samples from diagnostic biopsies or those who have progressed beyond standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of genomic alterations in prostate cancer, leading to more personalized treatment strategies.
How similar studies have performed: While the approach of identifying genomic alterations in prostate cancer is established, the specific focus on these cohorts and their genomic screening pathways may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Candiolo, Turin and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.