NCT05709535

PSMA-PET/CT Registry

PSMAN: POET PSMA-PET/CT Registry for High-Risk, Biochemically Relapsed, and Advanced Prostate Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective registry study to evaluate the diagnostic utility of \[18F\]-PSMA-1007 (PSMA-PET/CT) to stage patients with high-risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before onset of new therapy.

Detailed description

Prostate cancer is the most common non-skin malignancy and the third leading cause of cancer death in Canadian men. High-risk, recurrent, and metastatic prostate cancer is associated with poor patient outcomes. It is highly possible that the inability to accurately detect disease earlier in these patients is a key limiting factor in effectively treating patients with advanced prostate cancer. Prostate specific membrane antigen (PSMA) is seen on many patients' prostate cancer tumours, and that PSMA expression can not only help detect cancer earlier, but it can also help determine how to treat patients with both standard treatments (e.g., surgery or radiation), as well as systemic new medical treatments (e.g. \[177Lu\]-PSMA-617). The new imaging technology, PSMA PET/CT, has been shown to be more sensitive and specific for the detection of metastatic prostate cancer than the current standard of care imaging (CT and bone scan) and is starting to make its way into clinical use worldwide, but is not yet available outside of clinical trials in Canada. In recent years, prostate-specific membrane antigen (PSMA, glutamate carboxypeptidase II) has gained a resurgence of interest as a powerful imaging biomarker in prostate cancer. PSMA has been labelled with several single positron emission computed tomography (SPECT) and PET radiotracers to radiographically detect and stage the extent of disease in prostate cancer. This registry study will provide Alberta centres access to a new PET tracer, \[18F\]-PSMA-1007. A prospective registry study of PSMA PET/CT to guide therapy will allow enhanced access to PSMA-PET/CT and examine its effectiveness in characterizing patterns of extent, staging recurrence, and/or metastasis of high-risk prostate cancer, and to personalize therapies in men with prostate cancer. The aim is to determine the proportion of PSMA-PET/CT imaging with positive findings at local, regional, or distant sites.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[18F]-PSMA-1007	\[18F\]PSMA-1007 is a diagnostic radiopharmaceutical for Positron Emission Tomography (PET) scan. The intervention involves single intravenous administration of \[18F\]PSMA-1007 for PET scan.

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-02-02
• Last updated: 2024-12-18

Locations

1 site across 1 country: Canada