Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Blue Earth Diagnostics
• Collaborator: Parexel

Criteria

Inclusion Criteria:

1. Patient is male and aged >18 years old.

2. Histologically confirmed adenocarcinoma of the prostate.

3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

Exclusion Criteria:

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.

2. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).