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PRostate Cancer Plasma Integrative Multi-modal Evaluation

ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorSanta Chiara Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of prostate cancer

Eligible for prostate cancer pharmacological treatment

Given consent to study participation

Disqualifiers

None

Trial population

Patients are selected at oncology care clinics at participating clinical sites.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)

    Diagnostic test

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Metastatic Castration Resistant Prostate Cancer (mCRPC) patients1 intervention
Group B: Metastatic Hormon Sensitive Prostate Cancer (mHSPC) patients1 intervention

Trial outcomes

Primary outcomes

1

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
2

Quantification of the fraction of cfDNA hypo/hypermethylation

Rate of cfDNA hypo/hypermethylation

Time frame
From enrolment across different lines of treatment
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Santa Chiara Hospital

Lead sponsor

Università degli Studi di Trento

Collaborator

Source ClinicalTrials.gov
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