A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)

Trial Profile

A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2017

At a glance

  • Drugs Technetium tc 99m trofolastat (Primary)
  • Indications Prostate cancer
  • Focus Diagnostic use; Registrational
  • Acronyms proSPECT-AS
  • Sponsors Molecular Insight Pharmaceuticals
  • Most Recent Events

    • 03 Apr 2017 Planned End Date changed from 1 Sep 2017 to 1 Dec 2017.
    • 03 Apr 2017 Planned primary completion date changed from 1 Sep 2017 to 1 Dec 2017.
    • 22 Dec 2016 According to a Progenics Pharmaceuticals media release, a modification to the trial protocol has been proposed by the Company and agreed to by the U.S. Food and Drug Administration (FDA). The change permits patients with low to very low grade prostate cancer to participate in the trial without having to undergo a radical prostatectomy.
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