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Phase II Study of Zopocianine for Prostate Cancer Surgery

This study is testing different ways of giving Zopocianine (OTL78) to see if it can help surgeons better find and remove prostate cancer during surgery. Zopocianine is a special dye that glows under near-infrared (NIR) light, which helps highlight cancer cells that have spread beyond the prostate. We are looking for men aged 18 and older with known prostate cancer who are scheduled for prostate removal surgery and lymph node dissection. The main goal is to see how many people experience a significant event on the day of surgery. The study is currently unclear on its recruitment status and plans to enroll 22 participants.

Study design
This is an open-label study, meaning both you and the study team will know which dose of Zopocianine you receive. It involves 22 participants.
What's involved
You would receive a single dose of Zopocianine either on the day of surgery or the day before your prostate removal and lymph node dissection.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for this study is measured on the day of surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06849544

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

Completed
PHASE2Ages 18+InterventionalTreatment
Clinton Bahler
~22 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:0.03mg/kg ZOPOCIANINE given day of surgery0.06mg/kg ZOPOCIANINE given day of surgery0.03mg/kg ZOPOCIANINE given day prior to surgery0.06mg/kg ZOPOCIANINE given days prior to surgery

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Porportion of subjects who have a Clinically Significant Event
Measured over Day of surgery

Conditions

Prostate Cancer Surgery
Prostate Cancer Metastatic Disease

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Where it's being run

3 sites across 1 states
Indiana3

Study leadership

  • Clint Bahler, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Porportion of subjects who have a Clinically Significant EventDay of surgery

    1. Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy. 2. One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.