Metastatic Prostate Cancer (mPC)
Conditions
Brief summary
Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration
Detailed description
Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement. Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Exclusion criteria
* Unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy | 3 years | Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy in patients with metastatic prostate cancer (mPC) whose tumor tissue is inadequate or unavailable for molecular testing. |
Countries
Italy
Contacts
CONTACTElena Guerini Rocco, MD
CONTACTfrancesca lombardi, biologist
Outcome results
None listed