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 newly diagnosed prostate cancer
NOT ENROLLING
Trial ID:
NCT04186819 Protocol # :
20-073
Conditions
Prostate Cancer
Phase
III
Disease Sites
Prostate
Principal Investigator
Preston, Mark
Trial Description
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.
Eligibility Requirements
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).
20-073