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

Completed

• Conditions: Circulating Tumor DNA; Metastatic Prostate Cancer
• Interventions: Other: Blood sample; Other: Urine sample

• Registration Number: NCT05415787
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2022-08-18
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult patients with metastatic prostate cancer	Urine sample	-
adult patients with metastatic prostate cancer	Blood sample	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University hospital; 🇫🇷 Tours, France