Safety and Efficacy of OTL78
Public ClinicalTrials.gov record NCT07725523. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Safety and Efficacy of OTL78, a PSMA-targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07725523
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 45 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2026 (Estimated)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Sep 2027 (Estimated)
- Last update posted
- Oct 22, 2026
2026 – 2027
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University Health North Hospital | Carmel | Indiana | 46032 | Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07725523, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2026 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07725523 live on ClinicalTrials.gov.