News | Prostate Cancer | February 09, 2023

Results of the Investigational Phase 3 LIGHTHOUSE Study of 18F-rhPSMA-7.3 in newly diagnosed prostate cancer to be presented at 2023 ASCO Genitourinary Cancers Symposium (ASCO GU)

18F-rhPSMA-7.3 PET image showing multiple areas of uptake in the prostate gland in a man with newly diagnosed prostate cancer Photo courtesy of Blue Earth Diagnostics

18F-rhPSMA-7.3 PET image showing multiple areas of uptake in the prostate gland in a man with newly diagnosed prostate cancer Photo courtesy of Blue Earth Diagnostics 


February 9, 2023 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced the presentation of additional results from its completed Phase 3 LIGHTHOUSE trial of 18F-rhPSMA-7.3 in newly diagnosed prostate cancer, at the upcoming ASCO GU 2023 Genitourinary Cancers Symposium (ASCO GU). The conference will be held in San Francisco, Calif., from February 16 to 18, 2023. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. The now completed LIGHTHOUSE Phase 3 clinical trial (NCT04186819) was a prospective, Phase 3, multi-center, single-arm, imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 Positron Emission Tomography (PET) in men with newly diagnosed prostate cancer. Currently, 18F-rhPSMA-7.3 is investigational and has not received regulatory approval. 

Details of the presentation are listed below.

Date: 

Thursday, February 16, 2023 

Track: 

Prostate Cancer – Advanced Prostate Cancer - Localized 

Sub-Track: 

Diagnostics and Imaging 

Title: 

Detection of true positive M1 lesions by 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer: Results from the phase 3 prospective LIGHTHOUSE study. 

Presenter: 

Brian F. Chapin, MD, Associate Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, on behalf of Bridget F. Koontz, MD, Duke University Medical Center, and the LIGHTHOUSE Study Group. 

Session: 

Poster Session A: Prostate Cancer 

Abstract: 

315 

Location: 

Poster board K15 

Session Times: 

11:30 AM – 1:00 PM PT; 5:45 – 6:45 PM PT 

Blue Earth Diagnostics invites participants at the ASCO 2023 Genitourinary Cancers Symposium to attend the presentation above. Participants onsite are also invited to visit Blue Earth Diagnostics’ Medical Affairs booth (#21). For full session details and scientific presentation listings, please see the ASCO GU online program here. 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) 

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. The radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics GmbH in 2018, followed by acquisition of exclusive rights to therapeutic applications in 2020. Blue Earth Diagnostics has two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. rhPSMA compounds are investigational and have not received regulatory approval. 

For more information: www.blueearthdiagnostics.com 

Related Content: 

Blue Earth Diagnostics Announces Efficacy and Safety Results from Phase 3 LIGHTHOUSE Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Newly Diagnosed Prostate Cancer 

Blue Earth Diagnostics Announces Results on Clinical Factors Impacting Detection Rates from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer 

Independent Clinical Studies Published Regarding Performance of Axumin (Fluciclovine F 18) PET Imaging in Patients with Recurrent Prostate Cancer Undergoing Androgen Deprivation Therapy (ADT)    

Blue Earth Diagnostics Announces Additional Results from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA    

Blue Earth Diagnostics Announces Key Results from Phase 3 SPOTLIGHT Study of 18F-rhPSMA-7.3    

Majority of Recurrent Prostate Cancer Patients' Treatment Plan Changed Following Fluciclovine 18F PET/CT    

Blue Earth Diagnostics Announces Dosing of Initial Patient in Phase 3 REVELATE Clinical Trial of 18F-Fluciclovine PET Imaging for Detection of Recurrent Brain Metastases    

Blue Earth Diagnostics Highlights Presentations on Axumin (Fluciclovine F 18) and 18F-Fluciclovine at ASTRO21  


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