ClinicalTrials.gg
RecruitingNCT06762379L2-267Updated Sep 15, 2026

Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration

An observational study in Metastatic Prostate Cancer (mPC), sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by European Institute of Oncology · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
Male
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Study summary

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

02

Conditions studied

  • Metastatic Prostate Cancer (mPC)

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03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 125 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

European Institute of Oncology is the lead sponsor of 185 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with metastatic prostate cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written must be signed and dated by the patient and the investigator prior to inclusion.

Exclusion criteria

Exclusion Criteria:

  • Unable to provide written
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
125 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • patient with metastatic prostate cancer (mPC)
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2027, 36 months after the start.

Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 36 months is below that.

Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 31, 2024
First posted
Jan 7, 2025
StartActual
Dec 20, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2030
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06762379
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
Dec 20, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 15, 2026

Study contacts

Elena Guerini Rocco, MD
Contact
elena.guerinirocco@ieo.it
00390294372871
francesca lombardi, biologist
Contact
francesca.lombardi@ieo.it
00390257489425

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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