Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy (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.

The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

Inclusion Criteria:

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

2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.

3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

   • Following Radical Prostatectomy: PSA >0.2 ng/mL
   • Following Radiotherapy: nadir +2 ng/mL.

4. Potentially eligible for salvage therapy with curative intent.

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 Androgen Deprivation Therapy (ADT).