Actively Recruiting
Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection
Led by Clinton Bahler · Updated on 2026-05-05
22
Participants Needed
3
Research Sites
69 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 study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
CONDITIONS
Official 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...
- Provision of signed and dated informed consent and HIPAA form
- Male subjects 18 years of age and older
- Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following: suspected extraprostatic disease (extracapsular extension and/or seminal vesicle infiltration), 3 or more biopsy cores of grade group 3-5, suspected lymph node metastasis (clinical stage cN1, MRI positive, or PSMA PET positive)
- Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
- Ability to understand the study requirements and agree to follow study restrictions and attend required assessments
- Agree to use medically acceptable birth control or sexual abstinence during the study and through 6 weeks after dosing; sperm donation prohibited during study and for 3 months after dosing; female partners to use hormonal or barrier contraception unless postmenopausal or abstinent
You will not qualify if you...
- Surgeon plans to perform an extraperitoneal approach
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any components of Zopocianine including DUPA, polyethylene glycol-dipeptide linker, or chlorodye
- Impaired renal function (creatinine clearance < 50 mL/min)
- Impaired hepatic function (total bilirubin > 2 times upper limit normal or ALT/AST > 3 times upper limit normal)
- QTc interval ≥ 470 msec on ECG at screening
- Significant acute or chronic medical or neurological illness that could compromise safety, study completion, or objectives per investigator judgment
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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