An observational study in Metastatic Prostate Cancer, sponsored by Santa Chiara Hospital. Recruiting at 4 sites in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Santa Chiara Hospital · Observational
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 800 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Santa Chiara Hospital is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are selected at oncology care clinics at participating clinical sites.
Exclusion Criteria:
This group includes mCRPC patients treated with serial lines of treatment. For each line of treatment, blood samples are collected: 1. Before starting the treatment; 2. After 12 weeks; 3. At the end of the treatment/progression.
Diagnostic Test: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
This group includes mHSPC patients treated with hormone therapy. In the hormone sensitive setting, blood samples are collected: 1. Before starting the treatment; 2. After 12 weeks; 3. Every six months until progression to the castration resistant status.
Diagnostic Test: Analysis 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.
Quantification of circulating tumor DNA (ctDNA) in the plasma
Number of circulating tumor DNA (ctDNA) in the plasma
Time frame: From enrolment across different lines of treatment
Quantification of the fraction of cfDNA hypo/hypermethylation
Rate of cfDNA hypo/hypermethylation
Time frame: From enrolment across different lines of treatment
Presence of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, BRCA1/2, or AR amplification).
Assessment (yes/no) of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53,
Time frame: From enrolment across different lines of treatment
Presence of Copy Number Variants (CNVs) in ctDNA
Assessment (yes/no) of Copy Number Variants (CNVs) in ctDNA
Time frame: From enrolment across different lines of treatment
Identification of EV-associated biomarkers
Assessment (yes/no) of EV-associated biomarkers
Time frame: From enrolment across different lines of treatment
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