Dosing Begins in Trial of PET Imaging Agent to Detect Prostate Cancer’s Return

Dosing Begins in Trial of PET Imaging Agent to Detect Prostate Cancer’s Return
The first patients have been injected in a Phase 3 trial investigating the safety and performance of Blue Earth Diagnostics' imaging agent rhPSMA-7.3 (18F) in detecting prostate cancer in men with suspected disease recurrence, the company announced. The SPOTLIGHT trial (NCT04186845) is recruiting patients at several sites in the U.S. and at a single site in Finland. It aims to enroll about 300 men in whom prostate cancer is thought to have returned based on elevated prostate-specific antigen (PSA) levels after treatment. During the open-label study, participants will be given a single intravenous injection of the investigational imaging agent before undergoing a positron emission tomography (PET) scan. The trial's main goal is to assess the correct detection rate (CDR) and the positive predictive value (PPV) of rhPSMA-7.3 (18F), using tissue analysis or confirmatory imaging as a standard of truth. Safety of the imaging agent, also determined at 90 days after the injection, is a key secondary measure. CDR and PPV are both measures of diagnostic performance. CDR measures a test’s ability to correctly identify people with cancer, and PPV the test's ability to distinguish men with cancer from those without
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