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.
Inclusion Criteria:
Provision of signed and dated informed consent and HIPAA form
Male participants 18 years of age and older
Known primary prostate cancer and any one of the following:
Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.
Exclusion Criteria:
The surgeon plans to perform an extraperitoneal approach
History of anaphylactic reactions to products containing indocyanine green
History of allergy to any of the components of ZOPOCIANINE:
Impaired renal or hepatic function:
Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.
Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and/or compromise the objectives of the study.
brwgarve@iu.edu317-278-4766
A single dose of 0.06mg/kg ZOPOCIANINE (given 1-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
brwgarve@iu.edu317-278-4766
Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection
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