Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (NCT06849544) | Clinical Trial Compass
RecruitingPhase 2
Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection
United States22 participantsStarted 2025-04-02
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Provision of signed and dated informed consent and HIPAA form
✓. Male subjects 18 years of age and older
✓. Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following:
✓. Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
✓. 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
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: