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
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