Clinical Trials Logo
  1. Home
  2. Metastatic Prostate Cancer
  3. NCT05415787
  4. Details
NCT05415787 Clinical Trial

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

Metastatic Prostate Cancer Clinical Trial

— PROMECI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05415787
Other study ID # DR220119 PROMECI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 18, 2022
Est. completion date January 18, 2024

Study information
Verified date February 2024
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 18, 2024
Est. primary completion date January 17, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample
2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care.
• Urine sample
Urine sample is taken during the consultation carried out for the patient's care

Locations
Country Name City State
France University hospital Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Circulating plasma tumour DNA search for somatic variants of HRR genes (including BRCA1/BRCA2) Baseline
Primary Circulating urine tumour DNA search for somatic variants of HRR genes (including BRCA1/BRCA2) Baseline
Primary FFPE tissue search for somatic variants of HRR genes (including BRCA1/BRCA2) Baseline
See also
  Status Clinical Trial Phase
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Recruiting NCT04533958 - Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy N/A
Not yet recruiting NCT06009549 - A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients
Withdrawn NCT05771896 - Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC Phase 3
Completed NCT01981122 - A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer Phase 2
Completed NCT01233557 - Biomarkers of Bone Resorption in Metastatic Prostate Cancer N/A
Completed NCT01012141 - Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer Phase 2
Recruiting NCT04067713 - Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer
Active, not recruiting NCT04332744 - Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First) Phase 2
Completed NCT04545697 - mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer N/A
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Not yet recruiting NCT04031378 - Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer Phase 2
Completed NCT02278055 - Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer Phase 2
Completed NCT04193657 - Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
Completed NCT02260817 - Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer Phase 3
Terminated NCT00216060 - Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy Phase 3
Recruiting NCT04070209 - Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) Phase 2
Recruiting NCT04925648 - Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction Phase 2
Completed NCT01303705 - Anti-OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer Phase 1