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Metastatic Prostate CancerPRIMENCT06981377

PRostate Cancer Plasma Integrative Multi-modal Evaluation

An observational study of Metastatic Prostate Cancer, run by Santa Chiara Hospital at 4 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
How many people
800 participants
Where
4 sitesItaly
Study dates
7 May 2019to 31 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients are selected at oncology care clinics at participating clinical sites.

Who may be able to join

  • Diagnosis of prostate cancer
  • Eligible for prostate cancer pharmacological treatment
  • Given consent to study participation

Who cannot join

  • Histological diagnosis other than prostate cancer

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Orazio Caffo contact

+39 0461902121

orazio.caffo@apss.tn.it

Italy4 sites, 4 recruiting

  • Istituto Romagnolo per lo Studio dei Tumori

    Meldola, Forlì-Cesena, 47014

    Ugo De Giorgi, MD, PhD, 00390543739123, ugo.degiorgi@irst.emr.it

    Ugo De Giorgi, MD, PhD

    Recruiting

  • Azienda Ospedaliera San Luigi

    Orbassano, Torino, 10043

    Consuelo Buttigliero, MD, PhD, +390116705492, consuelo.buttigliero@unito.it

    Consuelo Buttigliero, MD, PhD

    Recruiting

  • Istituto Oncologico Veneto

    Padova, 35128

    Umberto Basso, MD, +39-049-8215953, umberto.basso@iov.veneto.it

    Basso Umberto

    Recruiting

  • Santa Chiara Hospital

    Trento, 38122

    Orazio Caffo, MD, +39 046190212, orazio.caffo@apss.tn.it

    Orazio Caffo

    Recruiting

Other trials in Italy

About this study

Official title: Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies

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).

Being tested
Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
Keywords
Liquid biopsy, Cell free DNA (cfDNA), Extracellular Vesicles (EVs), Biomarkers
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06981377
Study groupRoleWhat they receive
Metastatic Castration Resistant Prostate Cancer (mCRPC) patientsThis 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.
Receives: Diagnostic Test: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)
Metastatic Hormon Sensitive Prostate Cancer (mHSPC) patientsThis 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.
Receives: Diagnostic Test: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantification of circulating tumor DNA (ctDNA) in the plasma

    Number of circulating tumor DNA (ctDNA) in the plasma

    Measured: From enrolment across different lines of treatment

  2. Quantification of the fraction of cfDNA hypo/hypermethylation

    Rate of cfDNA hypo/hypermethylation

    Measured: 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,

    Measured: 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

    Measured: From enrolment across different lines of treatment

  5. Identification of EV-associated biomarkers

    Assessment (yes/no) of EV-associated biomarkers

    Measured: From enrolment across different lines of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start7 May 2019
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06981377
Sponsor's protocol ID
PRIME - AA Trento
Acronym
PRIME
Status last verified
May 2025
First submitted
14 Jan 2025
Last updated
20 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mugoni 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.

    PubMed 38046436

  • Orlando 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.

    PubMed 35664542

  • Conteduca 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.

    PubMed 34605002

  • Conteduca 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.

    PubMed 32669676

  • Wu 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.

    PubMed 32149736

  • Beltran H, Romanel A, Conteduca V, Casiraghi N, Sigouros M, Franceschini GM, Orlando F, Fedrizzi T, Ku SY, Dann E, Alonso A, Mosquera JM, Sboner A, Xiang J, Elemento O, Nanus DM, Tagawa ST, Benelli M, Demichelis F. Circulating tumor DNA profile recognizes transformation to castration-resistant neuroendocrine prostate cancer. J Clin Invest. 2020 Apr 1;130(4):1653-1668. doi: 10.1172/JCI131041.

    PubMed 32091413

  • Prandi D, Demichelis F. Ploidy- and Purity-Adjusted Allele-Specific DNA Analysis Using CLONETv2. Curr Protoc Bioinformatics. 2019 Sep;67(1):e81. doi: 10.1002/cpbi.81.

    PubMed 31524989

  • Vagner T, Spinelli C, Minciacchi VR, Balaj L, Zandian M, Conley A, Zijlstra A, Freeman MR, Demichelis F, De S, Posadas EM, Tanaka H, Di Vizio D. Large extracellular vesicles carry most of the tumour DNA circulating in prostate cancer patient plasma. J Extracell Vesicles. 2018 Aug 7;7(1):1505403. doi: 10.1080/20013078.2018.1505403. eCollection 2018.

    PubMed 30108686

  • Romanel A, Gasi Tandefelt D, Conteduca V, Jayaram A, Casiraghi N, Wetterskog D, Salvi S, Amadori D, Zafeiriou Z, Rescigno P, Bianchini D, Gurioli G, Casadio V, Carreira S, Goodall J, Wingate A, Ferraldeschi R, Tunariu N, Flohr P, De Giorgi U, de Bono JS, Demichelis F, Attard G. Plasma AR and abiraterone-resistant prostate cancer. Sci Transl Med. 2015 Nov 4;7(312):312re10. doi: 10.1126/scitranslmed.aac9511.

    PubMed 26537258

  • Carreira S, Romanel A, Goodall J, Grist E, Ferraldeschi R, Miranda S, Prandi D, Lorente D, Frenel JS, Pezaro C, Omlin A, Rodrigues DN, Flohr P, Tunariu N, S de Bono J, Demichelis F, Attard G. Tumor clone dynamics in lethal prostate cancer. Sci Transl Med. 2014 Sep 17;6(254):254ra125. doi: 10.1126/scitranslmed.3009448.

    PubMed 25232177

  • Prandi D, Baca SC, Romanel A, Barbieri CE, Mosquera JM, Fontugne J, Beltran H, Sboner A, Garraway LA, Rubin MA, Demichelis F. Unraveling the clonal hierarchy of somatic genomic aberrations. Genome Biol. 2014 Aug 26;15(8):439. doi: 10.1186/s13059-014-0439-6.

    PubMed 25160065

  • Franceschini GM, Quaini O, Mizuno K, Orlando F, Ciani Y, Ku SY, Sigouros M, Rothmann E, Alonso A, Benelli M, Nardella C, Auh J, Freeman D, Hanratty B, Adil M, Elemento O, Tagawa ST, Feng FY, Caffo O, Buttigliero C, Basso U, Nelson PS, Corey E, Haffner MC, Attard G, Aparicio A, Demichelis F, Beltran H. Noninvasive Detection of Neuroendocrine Prostate Cancer through Targeted Cell-free DNA Methylation. Cancer Discov. 2024 Mar 1;14(3):424-445. doi: 10.1158/2159-8290.CD-23-0754.

    PubMed 38197680

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Prostate Cancer, run by Santa Chiara Hospital at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Orazio Caffo (+39 0461902121, orazio.caffo@apss.tn.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of circulating tumor DNA (ctDNA) in the plasma (time frame: From enrolment across different lines of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06981377, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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