A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy of Targeted Intraprostatic Administration of PRX302 to Treat Men with Histologically Proven, Clinically Significant, Localised, Low- to Intermediate-Risk Prostate Cancer that is Associated with an MRI Lesion

Trial Profile

A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy of Targeted Intraprostatic Administration of PRX302 to Treat Men with Histologically Proven, Clinically Significant, Localised, Low- to Intermediate-Risk Prostate Cancer that is Associated with an MRI Lesion

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Dec 2017

At a glance

  • Drugs Topsalysin (Primary)
  • Indications Prostate cancer
  • Focus Adverse reactions
  • Sponsors Sophiris Bio
  • Most Recent Events

    • 11 Dec 2017 According to a Sophiris Bio media release, patients who cannot have experienced a clinically significant adverse event to topsalysin or the dosing procedure from the first dose can be retreated and final biopsy data on all patients who receive a second dose are expexcted in the fourth quarter of 2018.
    • 11 Dec 2017 Status changed from recruiting to active, no longer recruiting, according to a Sophiris Bio media release.
    • 02 Oct 2017 According to a Sophiris Bio media release, patient enrollment of this trial is near completion, and the remaining patients are being scheduled to receive treatment within the next few weeks. The company expects the study will be fully enrolled by the end of October 2017.
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