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
Clinton Bahler
Summary
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.
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 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…
Interventions
- Drug0.06mg/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
Locations (2)
- Indiana University Health North HospitalCarmel, Indiana
- Indiana University School of MedicineIndianapolis, Indiana