NCT07725523
Safety and Efficacy of OTL78
Recruiting · Phase 2, Phase 3 · Clinton Bahler · registry updated 2026-10-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
- Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
- Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography
Exclusion
- The surgeon plans to perform an extraperitoneal approach
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of ZOPOCIANINE:
- \[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA)
- Polyethylene glycol-dipeptide linker
- Impaired renal or hepatic function: