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Phase II Trial to Investigate the Safety and Efficacy of Three Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for the Intraoperative Imaging of Prostate Cancer

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Trial Profile

Phase II Trial to Investigate the Safety and Efficacy of Three Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for the Intraoperative Imaging of Prostate Cancer

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Oct 2025

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At a glance

  • Drugs OTL 78 (Primary)
  • Indications Prostate cancer
  • Focus Therapeutic Use

Most Recent Events

  • 21 Oct 2025 Planned End Date changed from 1 Sep 2025 to 1 Nov 2025.
  • 21 Oct 2025 Planned primary completion date changed from 1 Sep 2025 to 1 Nov 2025.
  • 16 May 2025 Planned number of patients changed from 15 to 20.

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