Blue Earth Diagnostics, a subsidiary of Bracco Imaging and a developer of PET radiopharmaceuticals, has entered into a data-sharing agreement with Siemens Healthineers for the use of anonymized clinical data from Blue Earth’s Phase 3 LIGHTHOUSE trial, which investigates POSLUMA (flotufolastat F 18) in newly diagnosed prostate cancer.

POSLUMA, an 18F-flotufolastat-labeled agent, targets Prostate-Specific Membrane Antigen (PSMA) for imaging prostate cancer in patients suspected of metastasis or recurrence. Siemens Healthineers aims to utilize the data to refine AI-driven algorithms on its syngo.via PET/CT imaging software, enhancing prostate cancer diagnosis and management.

“We believe that the LIGHTHOUSE trial data will be enormously helpful in tailoring our AI technology to support the quantification and clinical interpretation of POSLUMA PET/CT images and are pleased to collaborate with Blue Earth Diagnostics on this data-sharing agreement,” said Bruce Spottiswoode, director of clinical applications research for Siemens Healthineers. “The neural networks we are using have been shown to learn radiotracer-specific PET uptake, and we expect them to more efficiently identify clinically relevant features in 18F-flotufolastat images.”
The LIGHTHOUSE trial involved 356 patients across multiple sites in the U.S. and Europe, focusing on high-risk prostate cancer cases. The SPOTLIGHT study, another Phase 3 trial by Blue Earth, also investigated POSLUMA in suspected recurrent prostate cancer cases, enrolling 391 patients. These studies not only support the diagnostic efficacy of POSLUMA but also contribute to its recognition in clinical oncology guidelines and insurance coverage.

PETNET Solutions Inc., a Siemens Healthineers subsidiary and the main manufacturer and distributor of POSLUMA, announced last May that POSLUMA had become commercially available in the U.S. with FDA approval.

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