NCT05712174

A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer

A Phase II Study of Fluorine-18 (18F)-Labeled PSMA-1007 in Patients With Known or Suspected Metastatic Prostatic Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A \[18\]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. PSMA imaging utilizes this overexpression, by binding on the transmembrane receptor and internalization in the cancer cells. The internalized isotope can then be imaged with the use of a PET/CT or PET/MRI scanner and show where cancer cells may be present in the body. This imaging modality has been shown to be superior to conventional imaging, such as bone scan and CT, in the detection of prostate cancer tumors. The purpose of this study is to: 1) assess the clinical impact of a \[18\]F-PSMA-1007 scan on patient management plans; 2) assess the diagnostic effectiveness of a \[18\]F-PSMA-1007 scan in participants with known or suspected metastatic prostate cancer, as compared to standard of care CT chest, abdomen, pelvis and bone scan; 3) evaluate the safety of \[18\]F-PSMA-1007; and 4) assess potential correlations of PSMA level of uptake in certain tumors with cancer biologic markers such as PSA and Gleason score.

Detailed description

This is a Phase II, diagnostic imaging, controlled, open-label, single site study in four cohorts of patients with known or suspected metastatic prostate cancer. All participants will be imaged with \[18\]F-PSMA-1007 PET/CT; \[18\]F-PSMA-1007 PET/MRI may be performed instead of a PET/CT, if PET/MRI is available. The patients will be assessed for AEs after administration of \[18\]F-PSMA-1007, during their visit to the Nuclear Medicine Department. The assessment of impact on patient management will be performed using a questionnaire both before and after the \[18\]F-PSMA-1007 PET/CT or PET/MRI scan. The efficacy evaluation will consist of \[18\]F-PSMA-1007 PET/CT or PET/MRI clinical accuracy compared to standard of care CT and bone scan. Standard gadolinium-based contrast enhanced PET/MRI imaging may be performed if clinically indicated and if there are no contraindications. If a PET/MRI is performed, the clinical accuracy of the MRI component of the PET/MRI will be compared to the baseline CT. \[18\]F-PSMA-1007 uptake (SUVmax, Uptake Score) will be assessed in a selection of lesions and compared to PSA values collected on the day of the scan and Gleason score collected from the participant's medical history.

Conditions

• Oncology
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	[18]F-PSMA-1007	\[18\]F-PSMA-1007 is a diagnostic radiopharmaceutical for use with PET/CT or PET/MRI scanning to diagnose prostate cancer.

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-05-05
• Completion: 2025-05-05
• First posted: 2023-02-03
• Last updated: 2025-06-12

Locations

1 site across 1 country: Canada