RecruitingPhase 2NCT06849544

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


Sponsor

Clinton Bahler

Enrollment

22 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing four different dosing schedules of a drug called OTL78 — a fluorescent dye that attaches to prostate cancer cells and lights them up during surgery — to find the best dose for helping surgeons identify and remove prostate cancer tissue more accurately. **You may be eligible if...** - You are male and 18 years of age or older - You have confirmed prostate cancer that is high-grade (Grade Group 3 to 5) - Your cancer shows signs of spreading beyond the prostate capsule (extracapsular extension), into seminal vesicles, or involves multiple high-grade biopsy cores - You are scheduled for prostate surgery **You may NOT be eligible if...** - You have low or intermediate-grade prostate cancer (Grade Group 1 or 2) without high-risk features - You have kidney problems that would prevent safe use of this dye - You have a known allergy to related compounds - You are not scheduled for surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Hospital

Carmel, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

View Full Details on ClinicalTrials.gov

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NCT06849544


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