Safety and Efficacy of OTL78 (Zopocianine)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorClinton Bahler
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent and HIPAA form
Male participants 18 years of age and older
Grade group 3-5;
Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
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
Design model
Single group
Treatments tested in this trial
0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery
DrugA single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects who have a Clinically Significant Event
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.
Time frame
Day of surgerySecondary outcomes
1
Detection of Primary cancer
For primary cancer, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will consider disease state at four (4) defined prostate regions - right posterior, left posterior, anterior, and at the bladder neck
Time frame
Day of surgery2
Detection of Metastatic Cancer
For metastatic cancer spread to lymph nodes, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will use six (6) defined lymph node regions (external iliac, internal iliac, common iliac and right and left)
Time frame
Day of surgery3
Execution of pre-surgery plan
The pre-surgery plan will be documented and compared to the documented surgery performed if surgeon reports of changes in scope from initial plan.
Time frame
Day of surgery4
Incidence rates AEs and all SAEs
Incidence rates of all causally related AEs and all SAEs
Time frame
Screening to 6 week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinton Bahler
Lead sponsor
Indiana University
Sponsor institution
On Target Laboratories, LLC
Collaborator
Indiana University
Collaborator
Source ClinicalTrials.gov
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