Metastatic Prostate Cancer
Conditions
Keywords
Liquid biopsy, Cell free DNA (cfDNA), Extracellular Vesicles (EVs), Biomarkers
Brief summary
The study aims to develop PRIME (PRostate cancer plasma Integrative Multi-modal Evaluation) liquid biopsy test and to implement its use to query prospectively collected samples in advanced prostate cancer (PCa) clinical trials and/or clinical settings. In order to maximise the utility of liquid biopsies for advanced PCa, PRIME is focused on the development of novel computational and sequencing approaches that integrate multiple information from plasma circulating elements: i) cell free DNA (cfDNA) gene mutation data with accurate quantitation of cfDNA structural genomic changes, ii) cfDNA genomic profiling with cfDNA methylation status, and iii) the information provided by extracellular vesicles (EVs) and EV-associated cargo (including DNA, RNA and proteins).
Interventions
DIAGNOSTIC_TESTAnalysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
Plasma and buffy coat samples are shipped from the recruiting clinical sites to the lab of Professor Francesca Demichelis at the University of Trento (UniTN). At UniTN, samples are stored in dedicated freezers with restricted access and subsequently used as follows: * the plasma is used for the isolation of cell free DNA and extracellular vesicles (EVs); * the buffy coat is used for the extraction of genomic DNA. Nucleic acids sequencing library preparations and all downstream omics analyses are performed by Prof. Demichelis team.
Sponsors
Università degli Studi di Trento
Santa Chiara Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of prostate cancer * Eligible for prostate cancer pharmacological treatment * Given consent to study participation
Exclusion criteria
\- Histological diagnosis other than prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of circulating tumor DNA (ctDNA) in the plasma | From enrolment across different lines of treatment | Number of circulating tumor DNA (ctDNA) in the plasma |
| Quantification of the fraction of cfDNA hypo/hypermethylation | From enrolment across different lines of treatment | Rate of cfDNA hypo/hypermethylation |
| Presence of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, BRCA1/2, or AR amplification). | From enrolment across different lines of treatment | Assessment (yes/no) of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, |
| Presence of Copy Number Variants (CNVs) in ctDNA | From enrolment across different lines of treatment | Assessment (yes/no) of Copy Number Variants (CNVs) in ctDNA |
| Identification of EV-associated biomarkers | From enrolment across different lines of treatment | Assessment (yes/no) of EV-associated biomarkers |
Countries
Italy
Contacts
Primary ContactOrazio Caffo
Outcome results
None listed