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

Blue Earth Diagnostics

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Diagnostic Test: Positron Emission Tomography scan

Drug: rhPSMA-7.3 (18F) Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04186819

BED-PSMA-301

Details and patient eligibility

About

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.

Full description

Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation [BIE]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.

Enrollment

356 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is male and aged >18 years old.
Histologically confirmed adenocarcinoma of the prostate.
Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

Exclusion criteria

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, or with a prior history of, Androgen Deprivation Therapy (ADT).