Clinical Trial

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

Completed Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 changes
critical Trial completed 2026-08-14
minor Completion pushed: 2026-07 -> 2026-08-06 2026-08-14
critical Enrollment closed, study ongoing 2026-07-29
minor Completion moved earlier: 2026-08 -> 2026-07 2026-07-29
notable Primary completion pushed: 2026-05 -> 2026-07 2026-05-06
minor Completion pushed: 2026-06 -> 2026-08 2026-05-06
Trial Details
NCT Number NCT06849544
Lead Sponsor Clinton Bahler
Collaborators: Indiana University, On Target Laboratories, LLC
Conditions Prostate Cancer Surgery, Prostate Cancer Metastatic Disease
Enrollment 22 participants
Start Date 2025-04-02
Primary Completion 2026-06-15 (estimated)
Study Completion 2026-08-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-13