Clinical Trial · NCT04186845

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

Overview

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.

Sponsor

Blue Earth Diagnostics, LTD

Phase

Phase 3

ClinicalTrials.gov

NCT04186845

Drug / Compound

rhPSMA-7.3

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTAGA

Eligibility

Inclusion

Following Radiotherapy: nadir +2 ng/mL.
An elevated PSA, clinically suspicious for biochemically recurrent disease:
Potentially eligible for salvage therapy with curative intent.
Following Radical Prostatectomy: PSA \>0.2 ng/mL
History of localized adenocarcinoma of the prostate with prior curative intent treatment.

Exclusion

Patients currently receiving Androgen Deprivation Therapy (ADT).
Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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