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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Oct 2017

At a glance

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

    • 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.
    • 13 Sep 2017 According to a Sophiris Bio media release, 24-week biopsy data is expected by the end of the first quarter of 2018 and complete data on all patients, including those who receive a second dose of topsalysin, is expected to be available in the fourth quarter of 2018.
    • 08 Jun 2017 According to a Sophiris Bio media release, the first patient has been dosed in this trial.
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