Phase IIb Trial to Investigate the Safety and Efficacy of OTL78 Injection (Zopocianine)

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Clinton Bahler
Study ID
NCT07725523
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Prostate Cancer Metastatic Disease
  • Prostate Cancer Surgery

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery — DRUG
    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

Study Details

This study is being done to support the selection of single dose and timing regimen of Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Key Dates

First listed
Jul 24, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery
    A single dose of 0.06mg/kg ZOPOCIANINE (given 1-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Primary Outcome Measure

Proportion of subjects who have a Clinically Significant Event [ Time Frame: Day of surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana University Health North HospitalCarmelIndiana46032
Brandon Garver
[email protected]
317-278-4766
Clint Bahler, MD (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineIndianapolisIndiana46202
Brandon Garver
[email protected]
317-278-4766
Clint Bahler, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Health North Hospital· Carmel, INIndiana University School of Medicine· Indianapolis, IN

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