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Biomarkers for Neoadjuvant Pembrolizumab in Non-Metastatic Prostate Cancer Positive by 18FDG-PET Scanning

Study acronym: PICT-01
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv10
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  3. Notable Primary completion date: Nov 1, 2023 to Sep 1, 2024
    • Study completion date: May 30, 2024 to Mar 30, 2025
    v8
  4. Notable Primary completion date: Nov 1, 2022 to Nov 1, 2023
    • Study completion date: May 30, 2023 to May 30, 2024
    v7
  5. Notable Primary completion date: Nov 1, 2021 to Nov 1, 2022
    • Study completion date: Nov 30, 2022 to May 30, 2023
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 2 to 1v5
  2. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Sep 1, 2021 to Nov 1, 2021
    • Study completion date: Sep 1, 2022 to Nov 30, 2022
    • Start date changed from estimate of Dec 16, 2019 to Jan 10, 2020
  3. Notable Start date: Sep 1, 2019 to Dec 16, 2019
    • Primary endpoints revised (3)
    • Secondary endpoints revised (5)
    • Eligibility criteria expanded, about 4 words
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Different studies suggest that prostate cancer more likely to progress are more infiltrated by exhausted T cells expressing the cell surface protein PD1 (Programmed cell death 1). Therefore, there is a strong rationale for selecting patients at higher risk of progression for testing the efficacy of anti-PD1 therapy. High glucose metabolism as detected by fludeoxyglucose F18 (FDG)-positron emission tomography (PET) (18FDG-PET) imagery is an innovative biological biomarker-based method to identify patients at higher risk of recurrence and early failure to hormonotherapy. Recent study demonstrated that high intra-prostatic 18-FDG-uptake was associated with higher Gleason grades. Therefore the one third of Gleason ≥ 8 prostate cancer patients with higher 18FDG uptake would be ideal candidates for early immunotherapy treatments based on anti-PD-1 such as pembrolizumab. The study aimed to identify biomarkers predictive the response to Pembrolizumab given prior to radical prostatectomy in participants with primary prostate cancer at high risk of progression.
Trial Details
NCT Number NCT04009967
Lead Sponsor CHU de Quebec-Universite Laval
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)
Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov