NCT06849544

Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Clinton Bahler · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 20 subjects with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to explore the relationship between the amount of drug given, the timing of administration relative to surgery, and the utility of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.

Conditions

• Prostate Cancer Surgery
• Prostate Cancer Metastatic Disease

Interventions

Type	Name	Description
DRUG	0.03mg/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
DRUG	0.06mg/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
DRUG	0.03mg/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
DRUG	0.06mg/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

Timeline

• Start date: 2025-04-02
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-02-27
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study