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

Overseen By Stella Koumna, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

248 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 3 5 6}

Research Team

Stella Koumna, MD

Principal Investigator

Cross Cancer Institute, Alberta Health Services

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.)

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

Treatment Details

Interventions

• [18]F-PSMA-1007

Trial Overview [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.

Participant Groups

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.

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Findings from Research

In a study of 99 men with intermediate- or high-risk prostate cancer, 18F-PSMA-1007 PET/CT demonstrated high specificity (89.9%) for detecting lymph node involvement (LNI), but only moderate sensitivity (53.3%), indicating it is good at confirming the absence of disease but less effective at detecting it.

The results suggest that while 18F-PSMA-1007 PET/CT can provide useful information, it should not replace extended pelvic lymph node dissection (ePLND) for accurate staging in these patients, highlighting the need for further research to refine its role in clinical practice.

NCBI (Pubmed)

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. Hermsen, R., Wedick, EBC., Vinken, MJM., et al.[2022]

The 18F-PSMA 1007 radiotracer shows excellent performance in PET imaging for prostate cancer, with minimal urinary clearance and high spatial resolution, making it a promising tool for detecting metastatic lesions.

In a comparison study of two patients, both 64Cu-PSMA and 18F-PSMA-1007 provided high-quality images and similar detection capabilities for metastatic prostate cancer, suggesting that 64Cu-PSMA could be a viable alternative with a longer half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of 18F-PSMA-1007 and 64Cu-PSMA in 2 Patients With Metastatic Prostate Cancer. Cardoza-Ochoa, DR., Rivera-Bravo, B.[2023]

PSMA-based PET-CT imaging using fluorine-18 PSMA-1007 is effective for staging high-risk prostate cancer and locating recurrent disease, offering advantages like hepatobiliary excretion and a longer half-life compared to gallium tracers.

Despite its benefits, there are still some ambiguities and potential pitfalls in interpreting the results of PSMA-1007 imaging, which need to be considered in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography-computed tomography: normal patterns, pearls, and pitfalls. Foley, RW., Redman, SL., Graham, RN., et al.[2021]

The novel 18F-labelled PSMA-1007 ligand shows a significant increase in uptake in prostate cancer lesions over time, with maximum standardized uptake (SUVmax) rising from 10.98 at 60 minutes to 15.51 at 120 minutes post-injection, indicating improved detection capabilities.

Low accumulation of the tracer in the urinary bladder enhances the visibility of nearby prostate cancer lesions, although increased uptake in the liver may reduce the sensitivity for detecting liver metastases.

NCBI (Pubmed)

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. Rahbar, K., Afshar-Oromieh, A., Bögemann, M., et al.[2019]

The study involving 21 prostate cancer patients found that 18F-PSMA-1007 PET/CT had a significantly higher detection rate for primary prostate cancer lesions (100%) compared to 18F-FDG PET/CT (67%), indicating its superior efficacy in identifying cancerous tissues.

While 18F-PSMA-1007 showed excellent tumor uptake and differentiation between malignant and benign lesions, there is a risk of misdiagnosis due to non-tumor uptake, highlighting the need for careful analysis to improve diagnostic accuracy.

NCBI (Pubmed)

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. Zhou, X., Li, Y., Jiang, X., et al.[2022]

The new PET tracer 18F-PSMA-1007 shows promising results for detecting prostate cancer, with an effective dose similar to other PSMA-targeting agents and significantly reduced urinary clearance, allowing for better imaging of the prostate.

In a study involving 10 patients with high-risk prostate cancer, 18F-PSMA-1007 successfully detected 18 out of 19 lymph node metastases, demonstrating its efficacy in identifying small tumors and validating its diagnostic capabilities with histopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Giesel, FL., Hadaschik, B., Cardinale, J., et al.[2023]

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]

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]

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]

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]

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]

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]