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Recruiting NCT06981377

NCT06981377 PRostate Cancer Plasma Integrative Multi-modal Evaluation

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Clinical Trial Summary
NCT ID NCT06981377
Status Recruiting
Phase
Sponsor Santa Chiara Hospital
Condition Metastatic Prostate Cancer
Study Type OBSERVATIONAL
Enrollment 800 participants
Start Date 2019-05-07
Primary Completion 2027-01-31

Eligibility & Interventions

Sex Male only
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 800 participants in total. It began in 2019-05-07 with a primary completion date of 2027-01-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

Eligibility Criteria

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

Contact & Investigator

Central Contact

Orazio Caffo

✉ orazio.caffo@apss.tn.it

📞 +39 0461902121

Frequently Asked Questions

Who can join the NCT06981377 clinical trial?

This trial is open to male participants only, aged 18 Years or older, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06981377 currently recruiting?

Yes, NCT06981377 is actively recruiting participants. Contact the research team at orazio.caffo@apss.tn.it for enrollment information.

Where is the NCT06981377 trial being conducted?

This trial is being conducted at Meldola, Italy, Orbassano, Italy, Padova, Italy, Trento, Italy.

Who is sponsoring the NCT06981377 clinical trial?

NCT06981377 is sponsored by Santa Chiara Hospital. The trial plans to enroll 800 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology