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.
Prostate cancer (PCa) is the second leading cause of cancer-related death behind lung cancer. Prostate cells express Prostate Specific Membrane Antigen (PSMA), which is overexpressed in PCa cells in over 90% of patients. On Target has developed a PSMA-targeted agent, the drug product OTL78, that fluoresces under NIR illumination to help with the identification of prostate cancer tissue during resection surgery that has extended beyond the capsule of the prostate into adjacent tissue and lymph nodes. Intra-operative identification of cancer tissue using real-time imaging modalities that could improve tumor identification, demarcation and lymph node involvement may provide a very useful tool to reduce the frequency of residual cancer and increase complete removal of locally involved lymph nodes. This study is an open label trial of an imaging agent, PSMA targeted fluorescent dye (zopocianine, OTL78), in up to 32 participants with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to confirm the optimal dose and administration-to-surgery interval of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
Indiana University Health North Hospital
Carmel, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
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 surgery
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 surgery
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 surgery
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 surgery
Incidence rates AEs and all SAEs
Incidence rates of all causally related AEs and all SAEs
Time frame: Screening to 6 week follow-up
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