Phase IIb Trial to Investigate the Safety and Efficacy of OTL78 Injection (Zopocianine)

Safety and Efficacy of OTL78 (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial

This study is being done to support the selection of single dose and timing regimen of Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer Metastatic Disease; Prostate Cancer Surgery
• Intervention / Treatment: Drug: 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery

Detailed Description

Prostate cancer (PCa) is the second leading cause of cancer-related death behind lung cancer. Prostate cells express Prostate Specific Membrane Antigen (PSMA), which is overexpressed in PCa cells in over 90% of patients. On Target has developed a PSMA-targeted agent, the drug product OTL78, that fluoresces under NIR illumination to help with the identification of prostate cancer tissue during resection surgery that has extended beyond the capsule of the prostate into adjacent tissue and lymph nodes. Intra-operative identification of cancer tissue using real-time imaging modalities that could improve tumor identification, demarcation and lymph node involvement may provide a very useful tool to reduce the frequency of residual cancer and increase complete removal of locally involved lymph nodes.

This study is an open label trial of an imaging agent, PSMA targeted fluorescent dye (zopocianine, OTL78), in up to 32 participants with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to confirm the optimal dose and administration-to-surgery interval of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Brandon Garver; Phone Number: 317-278-4766; Email: brwgarve@iu.edu

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana University Health North Hospital
      • Contact: Brandon Garver; Phone Number: 317-278-4766; Email: brwgarve@iu.edu
      • Principal Investigator: Clint Bahler, MD
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
      • Contact: Brandon Garver; Phone Number: 317-278-4766; Email: brwgarve@iu.edu
      • Principal Investigator: Clint Bahler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery; A single dose of 0.06mg/kg ZOPOCIANINE (given 1-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.	Drug: 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery; A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who have a Clinically Significant Event	a) Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy. b) One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Primary cancer	For primary cancer, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will consider disease state at four (4) defined prostate regions - right posterior, left posterior, anterior, and at the bladder neck	Day of surgery
Execution of pre-surgery plan	The pre-surgery plan will be documented and compared to the documented surgery performed if surgeon reports of changes in scope from initial plan.	Day of surgery
Safety and tolerability of ZOPOCIANINE	Incidence rates of all causally related AEs and all SAEs	Screening to 6 week follow-up
Detection of Metastatic Cancer	For metastatic cancer spread to lymph nodes, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will use six (6) defined lymph node regions (external iliac, internal iliac, common iliac and right and left)	Day of surgery

Collaborators and Investigators

• Sponsor: Clinton Bahler
• Collaborators: Indiana University; On Target Laboratories, LLC
• Investigators: Principal Investigator: Clint Bahler, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Specific Membrane Antigen; Near infrared imaging; Fluorescent Imaging
• Other Study ID Numbers: UROL-CC-IUSCCC-0965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No