Safety and Efficacy of OTL78

This is a trial to assess the accuracy of an imaging agent, PSMA targeted fluorescent dye OTL78 (zopocianine), in combination with Near InfraRed (NIR) fluorescent imaging, to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing standard of care prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. This trial is intended to confirm results from previous Phase 2 dose finding studies and to support the dose selection for subsequent Phase 3 development.

Trial Details

NCT ID
NCT07725523
Phase
PHASE2 / PHASE3
Sponsor
Clinton Bahler
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • 0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery
Locations (sample)
  • Carmel, Indiana, United States|39.97837,-86.11804
  • Indianapolis, Indiana, United States|39.76838,-86.15804

Key Eligibility Criteria

  • Provision of signed and dated informed consent and HIPAA form
  • Male participants 18 years of age and older
  • Known primary prostate cancer and any one of the following:
  • Grade group 3-5;

For full eligibility, visit ClinicalTrials.gov.

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