NCT06762379

Brief Summary

Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
56mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Dec 2024Dec 2030

Study Start

First participant enrolled

December 20, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

December 31, 2024

Last Update Submit

March 23, 2026

Conditions

Metastatic Prostate Cancer (mPC)

Outcome Measures

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.

    3 years

Study Arms (1)

patient with metastatic prostate cancer (mPC)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic prostate cancer

You may not qualify if:

  • Unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of oncology

Milan, Italy, 20141, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Elena Guerini Rocco, MD

CONTACT

00390294372871elena.guerinirocco@ieo.it

francesca lombardi, biologist

CONTACT

00390257489425francesca.lombardi@ieo.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 7, 2025

Study Start

December 20, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

IT(1)