Metastatic Prostate Cancer (mPC)L2-267NCT06762379
Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration
An observational study of Metastatic Prostate Cancer (mPC), run by European Institute of Oncology at 1 site in Italy.
Trial summary
Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer (mPC)
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2024to 31 Dec 2030
- How long will I take part?
- 36 Months
- 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 with metastatic prostate cancer
Who may be able to join
- Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Who cannot join
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of oncology
Milan, Italy, 20141
elena Guerini Rocco, MD, +300294372871, elena.guerinirocco@ieo.it
About this study
Official title: Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC
Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration
Read the detailed description
Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.
Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients
- Conditions
- Metastatic Prostate Cancer (mPC)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with metastatic prostate cancer (mPC) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy in patients with metastatic prostate cancer (mPC) whose tumor tissue is inadequate or unavailable for molecular testing.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate Cancer (mPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762379
- Sponsor's protocol ID
- L2-267
- Acronym
- L2-267
- Status last verified
- Mar 2026
- First submitted
- 31 Dec 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC
- ClinicalTrials.gov ID
- NCT06762379
- Acronym / sponsor ID
- L2-267 / L2-267
- Conditions
- Metastatic Prostate Cancer (mPC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration
Detailed description
Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.
Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with metastatic prostate cancer (mPC) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic prostate cancer
Key inclusion criteria (1 listed)
- Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Key exclusion criteria (1 listed)
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy
Time frame: 3 years
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy in patients with metastatic prostate cancer (mPC) whose tumor tissue is inadequate or unavailable for molecular testing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Cancer (mPC), run by European Institute of Oncology at 1 site 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 1 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Elena Guerini Rocco, MD (00390294372871, elena.guerinirocco@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.