[18]F-PSMA-1007 Imaging for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Stella Koumna, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Inability to lie still, Allergic reaction, New therapy, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have started new therapy for prostate cancer within 4 weeks of enrollment, you may not be eligible to participate.

What data supports the effectiveness of the drug [18]F-PSMA-1007 for prostate cancer?

Research shows that [18]F-PSMA-1007 is effective in detecting prostate cancer, providing high-quality images and accurate staging, which helps in treatment decisions. It has advantages like minimal urinary clearance and higher spatial resolution, making it a promising option for imaging prostate cancer.

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Is [18]F-PSMA-1007 safe for use in humans?

The studies on [18]F-PSMA-1007, a tracer used in imaging for prostate cancer, do not report specific safety concerns, suggesting it is generally safe for human use. It is noted for its effective tumor detection and minimal urinary clearance, which are beneficial for imaging.

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How does the drug 18F-PSMA-1007 differ from other prostate cancer treatments?

18F-PSMA-1007 is unique because it is a radiotracer used in PET imaging for prostate cancer, offering minimal urinary clearance and higher spatial resolution compared to other tracers. It is excreted through the liver rather than the kidneys, which reduces interference in imaging, and its longer half-life allows for broader use in medical centers.

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Eligibility Criteria

Men over 18 with confirmed prostate cancer who can perform daily activities with some limitations (ECOG ≤2) are eligible. This includes those with high-risk, untreated localized cancer, intermediate risk factors, or biochemical recurrence after surgery or radiation. Participants must have recent standard imaging and be able to follow study procedures and provide consent. Exclusions include exceeding scanner weight limits, allergy to [18]F-PSMA-1007, severe claustrophobia or phobias of radiation, new therapy within 4 weeks for certain risks groups, or inability to remain still for imaging.

Inclusion Criteria

I am a man aged 18 or older.

I can take care of myself and am up and about more than half of my waking hours.

My prostate cancer diagnosis was confirmed through tissue or cell testing.

Exclusion Criteria

I can't stay still for long periods due to a condition like severe arthritis.

I started new treatment for my prostate cancer less than 4 weeks ago.

Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo a single [18]F-PSMA-1007 PET/CT or PET/MRI scan to assess diagnostic effectiveness and impact on patient management

1 day

1 visit (in-person)

Safety Assessment

Adverse events following [18]F-PSMA-1007 administration are assessed and graded

Up to 24 hours

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Participant Groups

[18]F-PSMA-1007 PET/CT or PET/MRI scans are being tested in this trial. These scans detect where PSMA-expressing cells are located in the body by using a radioactive substance that binds to prostate cancer cells. The trial aims to assess how well these scans work compared to conventional CT and bone scans in detecting metastatic prostate cancer and their impact on treatment plans.

Group I: [18]F-PSMA-1007 PET/CT or PET/MRI Experimental Treatment 1 Intervention

All participants will undergo a single \[18\]F-PSMA-1007 PET/CT or PET/MRI scan. Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cross Cancer Institute Edmonton, Canada

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Lymph node staging with fluorine-18 prostate specific membrane antigen 1007-positron emission tomography/computed tomography in newly diagnosed intermediate- to high-risk prostate cancer using histopathological evaluation of extended pelvic node dissection as reference. [2022] Label="PURPOSE">Fluorine-18 (18F) prostate-specific membrane antigen (PSMA) 1007 (18F-PSMA-1007) is a radiotracer used in prostate cancer (PCa) staging. So far, no large histopathological validation study has been conducted. The objective was to determine diagnostic accuracy of 18F-PSMA-1007 PET/CT compared to histopathological results of extended pelvic lymph node dissection (ePLND) in men with intermediate- or high-risk PCa.

2. United States pubmed.ncbi.nlm.nih.gov

A Comparison of 18F-PSMA-1007 and 64Cu-PSMA in 2 Patients With Metastatic Prostate Cancer. [2023] 18F-prostate-specific membrane antigen (PSMA) 1007 is one of the most promising radiotracers for PET imaging in prostate cancer, minimal urinary clearance, and higher spatial resolution, which are the most outstanding features. PSMA can also be labeled with 64Cu, offering a longer half-life and different resolution imaging. We present images of metastatic prostate cancer in two patients, where 64Cu-PSMA PET/CT was performed one day after 18F-PSMA-1007 PET/CT. In the two patients, both radiotracers provided high image quality and a similar range of detection for metastatic lesions.

3. England pubmed.ncbi.nlm.nih.gov

Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography-computed tomography: normal patterns, pearls, and pitfalls. [2021] Prostate-specific membrane antigen (PSMA)-based positron-emission tomography (PET)-computed tomography (CT) has shown great promise in prostate cancer imaging. This technique has demonstrated particular utility in the staging of high-risk primary cancer and in the localisation of recurrent disease. The use of fluorine-18 PSMA-1007 is advantageous, as it is excreted via the hepatobiliary system rather than urinary and the longer half-life of fluorine-18 compared to gallium tracers, allows for PSMA imaging in centres without a gallium generator. However, imaging with this tracer is not without flaws and areas of ambiguity remain. In this article, the biodistribution, clinical indications, and pearls of 18F-PSMA-1007 PET-CT in patients with prostate cancer will be discussed, as well as the potential pitfalls in the reporting of these studies.

4. Germany pubmed.ncbi.nlm.nih.gov

18F-PSMA-1007 PET/CT at 60 and 120 minutes in patients with prostate cancer: biodistribution, tumour detection and activity kinetics. [2019] Label="PURPOSE">PSMA-targeted PET in patients with prostate cancer (PCa) has a significant impact on treatment decisions. By far the most frequently used PSMA ligand is 68Ga-labelled PSMA-11. However, due to the availability of larger amounts of activity, 18F-labelled PSMA ligands are of major interest. The aim of the present study was to evaluate the biodistribution and performance of the novel 18F-labelled ligand PSMA-1007 at two different time points.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intra-Individual Comparison of 18F-PSMA-1007 and 18F-FDG PET/CT in the Evaluation of Patients With Prostate Cancer. [2022] 18F labelled PSMA-1007 presents promising results in detecting prostate cancer (PC), while some pitfalls exists meanwhile. An intra-individual comparison of 18F-FDG and 18F-PSMA-1007 in patients with prostate cancer were aimed to be performed in the present study. Then, the pitfalls of 18F-PSMA-1007 PET/CT in imaging of patients with prostate cancer were analyzed.

6. Germany pubmed.ncbi.nlm.nih.gov

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. [2023] Label="PURPOSE" NlmCategory="OBJECTIVE">The prostate-specific membrane antigen (PSMA) targeted positron-emitting-tomography (PET) tracer 68Ga-PSMA-11 shows great promise in the detection of prostate cancer. However, 68Ga has several shortcomings as a radiolabel including short half-life and non-ideal energies, and this has motivated consideration of 18F-labelled analogs. 18F-PSMA-1007 was selected among several 18F-PSMA-ligand candidate compounds because it demonstrated high labelling yields, outstanding tumor uptake and fast, non-urinary background clearance. Here, we describe the properties of 18F-PSMA-1007 in human volunteers and patients.