99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and / or are candidates for active surveillance, but have planned to undergo radical prostatectomy. In these patients, the results may be used to help estimate the risk of a histopathologic Gleason grade of > 3+4. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology.
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