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Results filtered:Study status: Open Closed for Enrollment
The purpose of this study is to investigate positive surgical margins (PSMs) in subjects undergoing RALP with (e)PLND after intravenous (IV) IS-002 administration with (Intervention arm) and without (Control arm) intraoperative near-infrared (NIR) fluorescence imaging.
The purpose of this study is to evaouate how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body.
99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.