NCT07725523RecruitingPhase 2/3
Safety and Efficacy of OTL78
Safety and Efficacy of OTL78, a PSMA-targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial Randomized Trial
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- Dec 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- Clinton Bahler
- Diseases
- Prostate cancer
- NCT number
- NCT07725523
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 45
- From Dec 2026 to the primary completion date, Jul 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of ZOPOCIANINE:
- 2-\[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA)
- Polyethylene glycol-dipeptide linker
- Chlorodye
- 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.
Lab values
- Impaired renal or hepatic function:
- Renal: creatinine clearance (eGFR) \< 50 mL/min
- Hepatic: total bilirubin \> 2 × upper limit of normal or ALT/AST \> 3 × upper limit of normal.
- Participant with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.
Other
- The surgeon plans to perform an extraperitoneal approach
Who the study is looking for
- 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
- Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- 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.
- Participant scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University Health North Hospital Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.