[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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special imaging scan called \[18\]F-PSMA-1007 PET/CT or PET/MRI. It aims to help doctors locate prostate cancer cells more accurately than traditional methods. The trial evaluates whether the scan alters treatment planning, its effectiveness compared to regular scans, and its safety. Men with confirmed prostate cancer showing signs of spreading or recurrence after treatment might qualify. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in prostate cancer detection.

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 prior data suggests that this imaging technique is safe for prostate cancer patients?

Research has shown that [18]F-PSMA-1007 is generally safe for people. Studies have found that this imaging agent is well-tolerated when used to detect prostate cancer. One study examined its safety in patients with suspected recurrent prostate cancer and found no major safety issues. The process involves a PET/CT or PET/MRI scan, which uses a small amount of radioactive material to detect cancer cells. Although still under testing, the absence of significant side effects so far suggests it is safe for use in these scans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18]F-PSMA-1007 because it offers a new way to visualize prostate cancer using PET/CT or PET/MRI scans. Unlike traditional imaging techniques, which may not always clearly differentiate cancerous tissue, this method uses a radioactive tracer that binds specifically to PSMA, a protein often found in high amounts on prostate cancer cells. This targeted approach potentially allows for more precise detection and staging of prostate cancer, which can lead to better treatment planning. Additionally, the ability to use either PET/CT or PET/MRI provides flexibility in imaging, accommodating different patient needs and equipment availability.

What evidence suggests that this imaging technique is effective for detecting prostate cancer?

Research shows that [18F]PSMA-1007 effectively detects prostate cancer. In this trial, participants will undergo a single [18F]PSMA-1007 PET/CT or PET/MRI scan. Studies have found that this imaging method surpasses traditional scans like bone scans and CTs in locating prostate cancer tumors. The tracer targets a protein called PSMA, often abundant on prostate cancer cells, making it easier to identify their location in the body. Various studies confirm its promising results in detecting prostate cancer. This imaging technique aids doctors in making better treatment decisions by providing clearer images of potential cancer sites. Overall, [18F]PSMA-1007 serves as a powerful tool for more accurate prostate cancer diagnosis. ^{2 4 6 7 8}

Who Is on the Research Team?

Stella Koumna, MD

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Are You a Good Fit for This Trial?

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 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.

Clinical criteria: High risk localized, treatment naive prostate cancer (clinical ≥T3a, Gleason score ≥8 or grade group 4-5, or PSA >20ng/mL); High-tier intermediate risk (at least two of clinical T2c, Gleason score ≥7 or Grade group 2-3, and PSA 10-20 ng/mL); Biochemically recurrent prostate cancer (persistently elevated or rising PSA after radical prostatectomy, with a PSA value of ≥0.2ng/mL on at least two readings, or PSA with a rise of at least ≥2 ng/mL above the nadir in patients who have received definitive radiation therapy); Metastatic disease documented on conventional imaging (CT and/or bone scan); 99m-Technecium bone scan and CT of the chest abdomen and pelvis within 4 weeks of study enrollment; Receipt of a complete [18]F-PSMA-1007 PET/CT or PET/MRI referral package, including baseline history information and treatment intent from the referring physician, prior to enrolment; Able and willing to follow instructions and comply with the protocol; Ability to provide written informed consent prior to participation in the study

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ... Introduction: PSMA PET/CT imaging has transformed prostate cancer detection, staging, and restaging. Key [¹⁸F]-based tracers ([¹⁸F]PSMA-1007 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854516/

Head-to-Head Comparison of [18F]PSMA-1007 and [18F]FDG ... The study involves 10 TNBC patients, revealing comparable uptake of [ 18 F]PSMA-1007 and [ 18 F]FDG in primary and metastatic lesions.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36418170/

Phase III Study of 18 F-PSMA-1007 ... The objective of this study was to compare 18 F-PSMA-1007 PET/CT and 18 F-fluorocholine PET/CT for the localization of prostate cancer (PCa) biochemical ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0969805121005345

Recent advancements in 18F-labeled PSMA targeting PET ... The clinically established 18F-PSMA PET tracers [18F]DCFPyL and [18F]PSMA-1007 have already demonstrated promising results for the detection of prostate cancer ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14301-x

Synthesizing [18F]PSMA-1007 PET bone images from CT ... This study explores deep learning (DL) techniques to synthesize [ 18 F]PSMA-1007 PET bone images from CT bone images for the early detection of bone metastases ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9906735/

Preclinical Evaluation of a Companion Diagnostic ... Our data from [18F]PSMA-1007 PET/computed tomography (CT) studies in a subcutaneous prostate cancer xenograft mouse model supports clinical ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04742361

NCT04742361 | Efficacy of [18F]PSMA-1007 PET/CT in ... This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/64/4/579

Phase III Study of 18F-PSMA-1007 Versus ... The objective of this study was to compare 18F-PSMA-1007 PET/CT and 18F-fluorocholine PET/CT for the localization of prostate cancer (PCa) ...