Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorClinton Bahler
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent and HIPAA form
Male subjects 18 years of age and older
Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)),
3 or more biopsy cores of grade group 3-5;
Disqualifiers
The surgeon plans to perform an extraperitoneal approach
History of anaphylactic reactions to products containing indocyanine green
2-[3-(1,3-dicarboxypropyl)ureido] pentanedioic acid (DUPA)
Polyethylene glycol-dipeptide linker
Trial design
Treatments tested in this trial
- 0.03mg/kg ZOPOCIANINE given day of surgery
- 0.06mg/kg ZOPOCIANINE given day of surgery
- 0.03mg/kg ZOPOCIANINE given day prior to surgery
- 0.06mg/kg ZOPOCIANINE given days prior to surgery
Treatment groups
22 Participants
are divided into 4 treatment groupsSponsors and collaborators
Clinton Bahler
Lead sponsor
Indiana University
Sponsor institution
Indiana University
Collaborator
On Target Laboratories, LLC
Collaborator
Source ClinicalTrials.gov