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

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Metastatic Prostate Cancer

Circulating Tumor DNA

Treatments

Other: Blood sample

Other: Urine sample

Study type

Observational

Funder types

Other

Identifiers

NCT05415787

DR220119 PROMECI

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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