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OpenTrials
Completed

NCT Number: NCT05415787

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

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.

Completed

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Key information

Conditions

Circulating Tumor DNA Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Cancer Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University hospital

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

Urine sample

Other

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

Primary outcomes

  1. Circulating plasma tumour DNA

    Time frame: Baseline

    search for somatic variants of HRR genes (including BRCA1/BRCA2)

  2. Circulating urine tumour DNA

    Time frame: Baseline

    search for somatic variants of HRR genes (including BRCA1/BRCA2)

  3. FFPE tissue

    Time frame: Baseline

    search for somatic variants of HRR genes (including BRCA1/BRCA2)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: PROMECI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2022
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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