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
Clinton Bahler
Summary
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.
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 i…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 under…
Interventions
- Drug0.03mg/kg ZOPOCIANINE given day of surgery
A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
- Drug0.06mg/kg ZOPOCIANINE given day of surgery
A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
- Drug0.03mg/kg ZOPOCIANINE given day prior to surgery
A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
- Drug0.06mg/kg ZOPOCIANINE given days prior to surgery
A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
Locations (3)
- Indiana University Health North HospitalCarmel, Indiana
- Indiana University Health Methodist HospitalIndianapolis, Indiana
- Indiana University School of MedicineIndianapolis, Indiana