PRostate Cancer Plasma Integrative Multi-modal Evaluation

Last updated: May 13, 2025
Sponsor: Santa Chiara Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metastatic Cancer

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

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

Clinical Study ID

NCT06981377
PRIME - AA Trento
  • Ages > 18
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of prostate cancer

  • Eligible for prostate cancer pharmacological treatment

  • Given consent to study participation

Exclusion

Exclusion Criteria:

  • Histological diagnosis other than prostate cancer

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
Phase:
Study Start date:
May 07, 2019
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Istituto Romagnolo per lo Studio dei Tumori

    Meldola, Forlì-Cesena 47014
    Italy

    Active - Recruiting

  • Azienda Ospedaliera San Luigi

    Orbassano, Torino 10043
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto

    Padova, 35128
    Italy

    Active - Recruiting

  • Santa Chiara Hospital

    Trento, 38122
    Italy

    Active - Recruiting

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