Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05415787

Acronym

PROMECI

Enrollment

Registered

2022-06-13

Start date

2022-08-18

Completion date

2024-01-18

Last updated

2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor DNA, Metastatic Prostate Cancer

Keywords

Prostate cancer, ctDNA, HR genes

Brief summary

Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.

Detailed description

The benefit of PARPi has been well established for ovarian (SOLO-1 study) and prostate cancer (PROFOUND study) with defects in the Homologous Recombination Repair (HRR) system due to BRCA1 or BRCA2 variants. Somatic variants in HRR genes are currently researched by Next Generation Sequencing (NGS). However, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (FFPE) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the PROFOUND study, highlighting a real pre-analytical matter when FFPE samples are used for NGS testing. Research of such alterations on circulating tumor DNA (ctDNA) extracted from plasma or urine could be a promising alternative test.

Interventions

OTHERBlood sample

2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care.

OTHERUrine sample

Urine sample is taken during the consultation carried out for the patient's care

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 years * Metastatic prostate cancer * Archived tissue sample available for testing for somatic variants of HRR genes (including BRCA1/BRCA2) * Free, informed and signed consent for research Non inclusion criteria * Refusal of blood and urine collection * Patient cognitively incapable of signing consent to participate in this study * Patient under guardianship or curatorship

Design outcomes

Primary

Measure	Time frame	Description
Circulating plasma tumour DNA	Baseline	search for somatic variants of HRR genes (including BRCA1/BRCA2)
Circulating urine tumour DNA	Baseline	search for somatic variants of HRR genes (including BRCA1/BRCA2)
FFPE tissue	Baseline	search for somatic variants of HRR genes (including BRCA1/BRCA2)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026