NCT06334809 INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
| NCT ID | NCT06334809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione del Piemonte per l'Oncologia |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-03-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Pasquale Rescigno, MD
PRINCIPAL INVESTIGATOR
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Frequently Asked Questions
Who can join the NCT06334809 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06334809 currently recruiting?
Yes, NCT06334809 is actively recruiting participants. Contact the research team at ilaria.buondonno@ircc.it for enrollment information.
Where is the NCT06334809 trial being conducted?
This trial is being conducted at Candiolo, Italy, Orbassano, Italy.
Who is sponsoring the NCT06334809 clinical trial?
NCT06334809 is sponsored by Fondazione del Piemonte per l'Oncologia. The principal investigator is Pasquale Rescigno, MD at Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo. The trial plans to enroll 400 participants.
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