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

Sponsor

University Hospital, Tours (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05415787

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Circulating Tumor DNA Metastatic Prostate Cancer	Other: Blood sample Other: Urine sample

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
adult patients with metastatic prostate cancer	Other: Blood sample 2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care. Other: Urine sample Urine sample is taken during the consultation carried out for the patient's care

Arm

Intervention/Treatment

adult patients with metastatic prostate cancer

Other: Blood sample

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

Other: Urine sample

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital	Tours		France	37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator: Matthias Tallegas, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Tours

ClinicalTrials.gov Identifier:

NCT05415787

Other Study ID Numbers:

DR220119 PROMECI

First Posted:

Jun 13, 2022

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Tours

Prostate cancer

ctDNA

HR genes

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jun 13, 2022