Phase IIb Trial of Zopocianine for Prostate Cancer Surgery

This study is testing a drug called Zopocianine (OTL78) to see how well it helps doctors find prostate cancer during surgery. Zopocianine is given as an injection 1-7 days before surgery. It works with a special camera (Near InfraRed or NIR fluorescent imaging) to make cancer cells glow, which could help surgeons remove all the cancer. The study is looking for men aged 18 and older who have prostate cancer that is more aggressive (Grade group 3-5) or suspected to have spread outside the prostate. The main goal is to see how many patients have a "Clinically Significant Event" (meaning cancer was found and removed) on the day of surgery. The current status of the study is unclear.

Study design
This is a Phase IIb, open-label study involving up to 36 male participants. It is testing a single dose of Zopocianine.
What's involved
You would receive a single injection of Zopocianine 1-7 days before your prostatectomy and lymph node dissection surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome 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.

NCT07725523

Safety and Efficacy of OTL78 (Zopocianine)

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Clinton Bahler
~36 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects who have a Clinically Significant Event
Measured over Day of surgery
Prostate Cancer Surgery
Prostate Cancer Metastatic Disease
2 sites across 1 states
Indiana2
  • Clint Bahler, MD · PRINCIPAL_INVESTIGATOR · Indiana University

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

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