Investigating a new imaging agent for prostate cancer surgery

Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for the Intraoperative Imaging of Prostate Cancer

This study is testing a new dye to see if it helps doctors find and remove more cancer during prostate surgery for men with prostate cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Indiana University (Academic / other)
• Locations: 3 sites (Carmel, Indiana and 2 other locations)
• Trial ID: NCT06849544 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of OTL78, a PSMA-targeted fluorescent dye, in improving the detection of malignant tissue during prostate cancer surgeries. The study involves administering different doses of OTL78 to adult male subjects scheduled for laparoscopic radical prostatectomy and pelvic lymph node dissection. By utilizing Near InfraRed (NIR) imaging, the trial aims to enhance the identification of cancerous tissues, potentially leading to more complete tumor removal and reduced residual cancer. The trial is open-label and will include up to 20 participants with biopsy-confirmed prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 18 and older with biopsy-confirmed prostate cancer and suspected extraprostatic disease or lymph node metastasis.

Not a fit: Patients with early-stage prostate cancer or those not scheduled for prostatectomy and lymph node dissection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve surgical outcomes for prostate cancer patients by enhancing the detection and removal of cancerous tissues.

How similar studies have performed: While the use of imaging agents in cancer surgery is not entirely novel, the specific application of OTL78 in prostate cancer surgery represents a potentially innovative approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent and HIPAA form
2. Male subjects 18 years of age and older
3. Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following:

   1. Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)),
   2. 3 or more biopsy cores of grade group 3-5;
   3. Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
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.

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.
6. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Where this trial is running

Carmel, Indiana and 2 other locations

• Indiana University Health North Hospital — Carmel, Indiana, United States (Recruiting)
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
• Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Clint Bahler, MD — Indiana University
• Study coordinator: Ashley Frazee, PhD

Conditions Prostate Cancer Surgery; Prostate Cancer Metastatic Disease; Prostate Specific Membrane Antigen; Fluorescent Imaging; Near infrared imaging