Clinical trial · Observational
PRostate Cancer Plasma Integrative Multi-modal Evaluation
Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Metastatic Castration Resistant Prostate Cancer (mCRPC) patients
- description
- 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.
- interventionNames
- Diagnostic Test: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
- label
- Metastatic Hormon Sensitive Prostate Cancer (mHSPC) patients
- description
- 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.
- interventionNames
- Diagnostic Test: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDMugoni V, Ciani Y, Quaini O, Tomasini S, Notarangelo M, Vannuccini F, Marinelli A, Leonardi E, Pontalti S, Martinelli A, Rossetto D, Pesce I, Mansy SS, Barbareschi M, Ferro A, Caffo O, Attard G, Di Vizio D, D'Agostino VG, Nardella C, Demichelis F. Integrating extracellular vesicle and circulating cell-free DNA analysis using a single plasma aliquot improves the detection of HER2 positivity in breast cancer patients. J Extracell Biol. 2023 Sep;2(9):e108. doi: 10.1002/jex2.108. Epub 2023 Sep 25. PMID 38046436
- BACKGROUNDOrlando F, Romanel A, Trujillo B, Sigouros M, Wetterskog D, Quaini O, Leone G, Xiang JZ, Wingate A, Tagawa S, Jayaram A, Linch M; PEACE Consortium; Jamal-Hanjani M, Swanton C, Rubin MA, Wyatt AW, Beltran H, Attard G, Demichelis F. Allele-informed copy number evaluation of plasma DNA samples from metastatic prostate cancer patients: the PCF_SELECT consortium assay. NAR Cancer. 2022 May 27;4(2):zcac016. doi: 10.1093/narcan/zcac016. eCollection 2022 Jun. PMID 35664542
- BACKGROUNDConteduca V, Scarpi E, Wetterskog D, Brighi N, Ferroni F, Rossi A, Romanel A, Gurioli G, Bleve S, Gianni C, Schepisi G, Lolli C, Cortesi P, Matteucci F, Barone D, Paganelli G, Demichelis F, Beltran H, Attard G, De Giorgi U. Plasma tumor DNA is associated with increased risk of venous thromboembolism in metastatic castration-resistant cancer patients. Int J Cancer. 2022 Apr 1;150(7):1166-1173. doi: 10.1002/ijc.33834. Epub 2021 Oct 13. PMID 34605002
- BACKGROUNDConteduca V, Wetterskog D, Scarpi E, Romanel A, Gurioli G, Jayaram A, Lolli C, Tandefelt DG, Schepisi G, Casadei C, Wingate A, Matteucci F, Paganelli G, Gonzalez-Billalabeitia E, Demichelis F, De Giorgi U, Attard G. Plasma tumour DNA as an early indicator of treatment response in metastatic castration-resistant prostate cancer. Br J Cancer. 2020 Sep;123(6):982-987. doi: 10.1038/s41416-020-0969-5. Epub 2020 Jul 16. PMID 32669676
- BACKGROUNDWu A, Cremaschi P, Wetterskog D, Conteduca V, Franceschini GM, Kleftogiannis D, Jayaram A, Sandhu S, Wong SQ, Benelli M, Salvi S, Gurioli G, Feber A, Pereira MB, Wingate AM, Gonzalez-Billalebeitia E, De Giorgi U, Demichelis F, Lise S, Attard G. Genome-wide plasma DNA methylation features of metastatic prostate cancer. J Clin Invest. 2020 Apr 1;130(4):1991-2000. doi: 10.1172/JCI130887.