Safety and Efficacy of OTL78 (Zopocianine)

Official record

Identifier

NCT07725523

Recruiting locations

country

United States

Interventions studied

0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery

Lead sponsor

Clinton Bahler

Target enrolment

36 participants

Study type

INTERVENTIONAL

Phase

Phase 2/3

Status

Not yet recruiting

First posted

Jul 24, 2026

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. Provision of signed and dated informed consent and HIPAA form
2. Male participants 18 years of age and older
3. Known primary prostate cancer and any one of the following:

   1. Grade group 3-5;
   2. Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
   3. Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography
4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
6. Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
7. Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.

Exclusion Criteria:

1. The surgeon plans to perform an extraperitoneal approach
2. History of anaphylactic reactions to products containing indocyanine green
3. History of allergy to any of the components of ZOPOCIANINE:

   1. 2-\[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA)
   2. Polyethylene glycol-dipeptide linker
   3. Chlorodye
4. Impaired renal or hepatic function:

   1. Renal: creatinine clearance (eGFR) \< 50 mL/min
   2. Hepatic: total bilirubin \> 2 × upper limit of normal or ALT/AST \> 3 × upper limit of normal.
5. Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.
6. Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and/or compromise the objectives of the study.