Developing a liquid biopsy test for advanced prostate cancer
Official title: Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies
Run by Santa Chiara Hospital · NCT06981377 · Data updated 2026-11-12
This study is testing a new blood test for advanced prostate cancer to see if it can help doctors make better treatment decisions by analyzing different genetic information.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 800 (estimated) |
| Sponsor | Santa Chiara Hospital Academic / other |
| Locations | 4 sites (Meldola, Forlì-Cesena and 3 other locations) |
| Status | Recruiting |
| Started | May 7, 2019 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | May 20, 2025 |
| Trial ID | NCT06981377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with prostate cancer who are eligible for pharmacological treatment.
✕Probably not a fit
Patients with histological diagnoses other than prostate cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on creating the PRIME liquid biopsy test to analyze plasma samples from patients with metastatic prostate cancer. It aims to integrate various data types, including cell free DNA (cfDNA) mutations, structural genomic changes, and extracellular vesicle (EV) information. By employing advanced computational and sequencing techniques, the study seeks to enhance the diagnostic utility of liquid biopsies in clinical settings and trials for advanced prostate cancer. The goal is to provide a comprehensive evaluation of biomarkers that could inform treatment decisions.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and personalized treatment options for patients with metastatic prostate cancer.
How similar studies have gone: Other studies utilizing liquid biopsies and cfDNA analysis have shown promise in cancer diagnostics, suggesting that this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena, Italy Recruiting -
Azienda Ospedaliera San Luigi
Orbassano, Torino, Italy Recruiting -
Istituto Oncologico Veneto
Padova, Italy Recruiting -
Santa Chiara Hospital
Trento, Italy Recruiting
Study contacts
- Study coordinator: Orazio Caffo
- Email: orazio.caffo@apss.tn.it
- Phone: +39 0461902121
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JANX013 and JANX007 combo in advanced prostate cancer
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PSMA PET-Staged Progression-Directed Radiotherapy for Limited Prostate Cancer Progression
A real-world registry tests how well comprehensive progression-directed radiotherapy works for men with metastatic prostate cancer who show a small number of progressing lesions while on systemic therapy.
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Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer
This registry follows men with new, limited metastatic prostate cancer who receive targeted radiotherapy to the prostate and all visible metastases to see how they do over time in real-world care.
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PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer
This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.
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First-in-human imaging test of the GRPR-targeted theranostic pair for advanced breast or prostate cancer
This early feasibility study tests a GRPR-targeted imaging agent for PET and a low-dose radiopharmaceutical for SPECT in adults with advanced breast or prostate cancer to see if it is safe and can image tumors.
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Combined treatment approach in metastatic prostate cancer using AZD2265 (FPI-2265) with palacaparib or docetaxel
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.