UK-based molecular imaging company Blue Earth Diagnostics has announced dosing of first patient in its Phase 3 LIGHTHOUSE clinical trial of targeted PET imaging agent rhPSMA-7.3 (18F) in newly diagnosed prostate cancer.

The LIGHTHOUSE Phase 3 clinical trial is a prospective, multi-center, single-arm, imaging study scrutinising the safety and diagnostic performance of rhPSMA-7.3 ( 18F) positron emission Tomography (PET) in men suffering from prostate cancer.

rhPSMA-7.3 (18F) comprises a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalised by prostate cancer cells. It is labeled with the 18F radioisotope for PET imaging.

Phase 3 LIGHTHOUSE clinical trial will enroll approximately 375 evaluable patients at clinical sites in the US and Europe

Nearly 375 evaluable patients will be enrolled for the study at clinical sites in the US and Europe.

The primary endpoints of the study are to evaluate the sensitivity and specificity of rhPSMA-7.3 (18F) PET for detecting pelvic lymph node metastases in comparison to surgical pathology on a patient level.

The secondary endpoints of the Phase 3 LIGHTHOUSE clinical trial will assess the safety of rhPSMA-7.3 (18F) in patients and determine inter- and intra-reader agreement of rhPSMA-7.3 (18F) scan interpretations by blinded independent readers.

The company stated that the first patient in the study was dosed in Los Angeles, California located at RadNet’s Liberty Pacific Advanced Imaging Center in conjunction with Tower Urology.

Blue Earth Diagnostics CEO Jonathan Allis said: “We are excited to initiate this Phase 3 imaging trial of rhPSMA-7.3 (18F), with the hope that it may help address the needs of men with newly diagnosed prostate cancer.

“LIGHTHOUSE is part of our strategy to expand and advance a world-leading prostate cancer imaging portfolio, alongside our planned Phase 3 clinical trial investigating the use of rhPSMA-7.3 (18F) PET imaging in patients with an elevated Prostate-Specific Antigen (PSA) level after prior therapy.

“rhPSMA-7.3 (18F) and approved, commercially available Axumin® (fluciclovine F 18) have unique and complementary mechanisms of action, and we believe both compounds may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation.”