Real world experience with [99mTc]Tc-HYNIC-iPSMA SPECT prostate cancer detection: interim results from the global NOBLE registry.

Abstract

Purpose: [^99mTc]Tc-HYNIC-iPSMA is a novel technetium-99m-labelled small molecule inhibitor of the prostate-specific membrane antigen (PSMA) for detecting prostate cancer (PC). The objective of this registry was to collect and evaluate [^99mTc]Tc-HYNIC-iPSMA patient data and images to establish the safety and tolerability, and clinical utility of this agent in imaging at different stages of PC.

Methods: Patients 18 to 80 years old with primary staging and metastatic PC were eligible. Patients unable to perform prescribed examinations, undergo a [^99mTc]Tc-HYNIC-iPSMA planar and SPECT or SPECT/CT (when available), or sign a patient informed consent form were excluded from the registry. All eligible patients underwent a screening and baseline visit before imaging with [^99mTc]Tc-HYNIC-iPSMA. The primary safety endpoint was assessed by collecting and grading all treatment-related adverse events using the Common Terminology Criteria for Adverse Events. Patients were followed until disease progression, death, serious or intolerable adverse events, registry termination by the sponsor, patient withdrawal, or lost to follow-up. Analysis was planned for when data was available from 40 enrolled patients.

Results: 40 patients enrolled in 6 countries and received [^99mTc]Tc-HYNIC-iPSMA tracer administration followed by planar and SPECT imaging. Of the 40 patients included, investigators reported a change in management due to the [^99mTc]Tc-HYNIC-iPSMA imaging in 17/40 of patients (42.5%). No adverse events were reported.

Conclusions: [^99mTc]Tc-HYNIC-iPSMA is a promising option to identify PSMA-positive prostate cancer on SPECT and could improve patient access to PSMA imaging worldwide.