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RECRUITING
NCT07725523
PHASE2/PHASE3

Safety and Efficacy of OTL78

Sponsor: Clinton Bahler

View on ClinicalTrials.gov

Summary

This is a trial to assess the accuracy of an imaging agent, PSMA targeted fluorescent dye OTL78 (zopocianine), in combination with Near InfraRed (NIR) fluorescent imaging, to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing standard of care prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. This trial is intended to confirm results from previous Phase 2 dose finding studies and to support the dose selection for subsequent Phase 3 development.

Official title: Safety and Efficacy of OTL78, a PSMA-targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial Randomized Trial

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-12

Completion Date

2027-09

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery

A single dose of 0.06 mg/kg ZOPOCIANINE used with NIR fluorescent imaging following completion of planned prostatectomy and lymph node dissection

Locations (2)

Indiana University Health North Hospital

Carmel, Indiana, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States