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The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment

Study acronym: BARCODE2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 30, 2025 to Dec 31, 2026
    • Study completion date: Sep 30, 2025 to Dec 31, 2028
    v18
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 450 to confirmed 305
    • Site details revised
    v17
  3. Primary and study completion dates: Sep 30, 2024 to Sep 30, 2025
    • Site contact updated
    v16
  4. Eligibility criteria expanded, about 8 words
    • Study description expanded, about 25 words
    • Collaborators: 16 to 12
    v15
  5. Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Apr 25, 2022 to Sep 30, 2024v13
  2. Re-verified, no change to tracked fieldsv12
  3. Eligibility criteria shortened, about 62 words
    • Study description expanded, about 50 words
    v11
  4. Primary completion date: Sep 30, 2020 to Apr 25, 2022v10 Show 5 more changesShow less
    • Primary endpoints: 2 to 3
    • Study completion date: Apr 25, 2022 to Sep 30, 2024
    • Eligibility criteria expanded, about 114 words
    • Secondary endpoints: 7 to 8
    • Collaborators: 20 to 16
  5. Re-verified, no change to tracked fieldsv9
  6. Primary completion date: May 25, 2019 to Sep 30, 2020v8
  7. 2 versions Re-verified since Aug 30, 2018, no change to tracked fieldsv6-v7
  8. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: May 2019 to May 25, 2019
    • Study completion date: Apr 2022 to Apr 25, 2022
    • Start date changed from estimate of May 2017 to May 25, 2017
    • Site details revised
  9. Primary completion date: Apr 2019 to May 2019
    • Study completion date: Mar 2022 to Apr 2022
    • Start date: Apr 2017 to May 2017
    v4
  10. Primary completion date: Feb 2019 to Apr 2019
    • Start date: Mar 2017 to Apr 2017
    • Secondary endpoints: details revised at 1 of 7 entries
    v3
  11. Start date: Dec 2016 to Mar 2017
    • Primary completion date: Nov 2018 to Feb 2019
    • Study completion date: Dec 2021 to Mar 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prostate cancer (PrCa) is one of the commonest cancer in men in the Western world. In the United Kingdom (UK), there were over 52,000 new cases diagnosed in 2016-2018 and a lifetime risk of 1 in 8. Research studies have identified several genetic changes that are thought to increase the risk of developing prostate cancer. Some of these genetic changes occur in deoxyribonucleic acid (DNA) repair genes. The BARCODE 2 trial is formed of two parts that aim to investigate how having genetic changes in DNA repair genes can affect response to carboplatin treatment in patients with metastatic castration resistant prostate cancer (mCRPC). In part 1 of the study, the investigators will invite men with mCRPC who have not had genetic testing before to join the study by initially undergoing genetic screening within the study. The DNA repair gene mutation carrier status of enrolled patients will be assessed using a gene panel. If a pathogenic mutation is confirmed in one of these genes, patients will be given the option to proceed to part 2 of the study. In part 2 of the study, men with mCRPC who are known to be carriers of a mutation in DNA repair gene(s) will be assessed for eligibility for treatment on the study with carboplatin chemotherapy. The aim of the study will be to determine how patients with mCRPC and a germline mutation in a DNA repair gene(s) respond to platinum chemotherapy. This study will help researchers to investigate platinum sensitivity of prostate tumours that have developed due to a germline mutation in a DNA repair gene. This study will provide data to use in a larger clinical trial of platinum chemotherapy based on patients' germline genetic signature and/or tumour genetic profile.
Trial Details
NCT Number NCT02955082
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Royal Marsden NHS Foundation Trust, European Research Council, Imperial College Healthcare NHS Trust, Dartford and Gravesham NHS Foundation Trust, Maidstone & Tunbridge Wells NHS Trust, East and North Hertfordshire NHS Trust, Royal Free Hampstead NHS Trust, Buckinghamshire Healthcare NHS Trust, Barts & The London NHS Trust, Nottingham University Hospitals NHS Trust, Yeovil District Hospital NHS Foundation Trust, Northampton General Hospital NHS Trust
Conditions
(from sponsor)		 Hormone Refractory Prostate Cancer
Enrollment 305 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov