Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06849544 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection
A Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery, sponsored by Clinton Bahler.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT06849544: Recruiting Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery, sponsored by Clinton Bahler.
NCT06849544 is a Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery that is actively recruiting participants, run by Clinton Bahler. The registered enrollment target is 22 participants, below the 51-participant average among 5 other Prostate Cancer Metastatic Disease trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06849544, a Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery, is actively recruiting participants, sponsored by Clinton Bahler.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 0.03mg/kg ZOPOCIANINE given day of surgery
- DRUG 0.06mg/kg ZOPOCIANINE given day of surgery
- DRUG 0.03mg/kg ZOPOCIANINE given day prior to surgery
- DRUG 0.06mg/kg ZOPOCIANINE given days prior to surgery
Study Locations (3)
Indiana
- Indiana University Health North Hospital - Carmel
- Indiana University Health Methodist Hospital - Indianapolis
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-04-02 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06849544 shows while recruiting
NCT06849544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 51-participant average among 5 other Prostate Cancer Metastatic Disease trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Prostate Cancer Metastatic Disease appearing as the primary indexed condition, and to 4 interventions - of which 0.03mg/kg ZOPOCIANINE given day of surgery is the first listed.
NCT06849544 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT06849544 about?
NCT06849544 is a clinical study titled "Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection". 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 prosta...
What is the current status of trial NCT06849544?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2025-04-02. Estimated completion is 2026-06.
What conditions does trial NCT06849544 study?
This clinical trial studies the following conditions: Prostate Cancer Metastatic Disease, Prostate Cancer Surgery.
What interventions are being tested in trial NCT06849544?
The interventions under investigation include: 0.03mg/kg ZOPOCIANINE given day of surgery (DRUG), 0.06mg/kg ZOPOCIANINE given day of surgery (DRUG), 0.03mg/kg ZOPOCIANINE given day prior to surgery (DRUG), 0.06mg/kg ZOPOCIANINE given days prior to surgery (DRUG).
Who is sponsoring clinical trial NCT06849544?
This trial is sponsored by Clinton Bahler, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06849544 being conducted?
This trial has 3 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer Metastatic Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Using FAPI PET/MRI to Evaluate Prostate Cancer
RECRUITING · Phase 2
-
Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
RECRUITING · Phase 2
-
PSMA PET for Surveillance After Focal Therapy
RECRUITING · NA
-
A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
RECRUITING · Phase 1
-
Role of Race in Nutritional Approach in Men on ADT
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI