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A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca Depot Injection into the Prostate in Patients with Localized Prostate Cancer, Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))

Trial Profile

A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca Depot Injection into the Prostate in Patients with Localized Prostate Cancer, Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Dec 2019

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At a glance

  • Drugs Hydroxyflutamide (Primary)
  • Indications Prostate cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors LIDDS
  • Most Recent Events

    • 02 Dec 2019 According to a LIDDS media release, Professor Laurence Klotz is one of the study investigators for this study.
    • 02 Dec 2019 Results published in the LIDDS media release
    • 18 Nov 2019 Primary endpoint has been met. (Responder rate, absolute levels and % decrease in Prostate Specific Antigen (PSA) 20 weeks after treatment for the doses of Liproca Depot selected in Stage II. A responder is defined as a patient with a PSA decrease of at least 15%)
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