Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.
- Prostate Cancer
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Patient is male and aged >18 years old.
- History of localized adenocarcinoma of the prostate with prior curative intent treatment.
- An elevated PSA, clinically suspicious for biochemically recurrent disease:
- Following Radical Prostatectomy: PSA >0.2 ng/mL
- Following Radiotherapy: nadir +2 ng/mL.
- Potentially eligible for salvage therapy with curative intent.
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
- Patients currently receiving Androgen Deprivation Therapy (ADT).
- Phase 3
- Study Type
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Positron Emission Tomography (PET) Imaging study
- Primary Purpose
- None (Open Label)
|Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan||
- Blue Earth Diagnostics
Study ContactJingke Yang, MD
+1 978 313 3834