Actively Recruiting
Phase II Trial to Investigate Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (Zopocianine), a PSMA-Targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer
Led by Clinton Bahler · Updated on 2026-05-05
22
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Clinton Bahler
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the use of Zopocianine (OTL78), a fluorescent drug that targets Prostate Specific Membrane Antigen (PSMA), to improve detection of cancerous tissue during prostate surgery. It focuses on men with biopsy-confirmed prostate cancer who are scheduled for prostate removal and lymph node dissection. The study aims to better visualize tumors and affected lymph nodes to potentially reduce leftover cancer and improve surgery outcomes. Participants receive one dose of Zopocianine at varying amounts (0.03 or 0.06 mg/kg) and timings before surgery, ranging from 1 hour to 7 days prior. The drug is used together with Near InfraRed (NIR) fluorescent imaging during surgery to help identify cancer tissue. Four different dosing schedules are compared to assess safety and how well each helps detect cancerous tissue during the operation. During the study, participants undergo standard surgery with added imaging using the study drug. Researchers monitor safety from screening through 6 weeks after surgery, tracking any significant events on the day of surgery. They also evaluate how well the drug detects primary and metastatic cancer and if the planned surgery is carried out as intended. Follow-up assessments and safety checks continue for several weeks after the procedure.
CONDITIONS
Brief Title
Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA form
- Male subjects 18 years or older
- Diagnosed with primary prostate cancer Grade Group 3 to 5 (≥ cT3) or have suspected spread beyond prostate or lymph node involvement
- Scheduled for standard robotic prostatectomy and lymph node dissection
- Able to understand study requirements and comply with study procedures
- Agree to use medically acceptable birth control or abstinence during the study and follow contraceptive guidelines for partners
You will not qualify if you...
- Surgery planned using an extraperitoneal approach
- History of severe allergic reactions to indocyanine green
- Allergy to any component of Zopocianine including DUPA, polyethylene glycol-dipeptide linker, or chlorodye
- Impaired kidney (eGFR < 50 mL/min) or liver function (bilirubin > 2× normal or ALT/AST > 3× normal)
- QTc interval ≥ 470 msec on ECG at screening
- Significant acute or chronic illness that may affect safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 2 to 7 days prior to day of surgery
Participants receive a single dose of ZOPOCIANINE at various times before surgery to assist with fluorescent imaging during prostatectomy and lymph node dissection.
1 dosing visit and 1 surgery visit
Duration - Up to 6 weeks after surgery
Participants are monitored for safety and tolerability of ZOPOCIANINE after surgery.
Approximately 3 follow-up visits
Trial Site Locations
Total: 3 locations
1
Indiana University Health North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Ashley Frazee, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here