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Study on Metastatic Prostate Cancer: Evaluating [18F]FAPI-74 and Piflufolastat (18F) for Patients with Advanced Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying prostate cancer, specifically when it has spread to other parts of the body, known as metastatic prostate cancer. The study will use two different treatments: [18F]FAPI-74 and 18F-DCFPyL. Both of these are solutions for injection that help doctors see cancer cells more clearly during imaging tests. The purpose of the study is to evaluate how well these treatments can identify specific proteins associated with prostate cancer, which are called prostate-specific membrane antigen (PSMA) and fibroblast activation-protein (FAP).

Participants in the study will receive injections of these treatments, which are given through a vein, a method known as intravenous injection. The study will compare how well each treatment works in detecting cancer that has spread. This will help doctors understand which treatment might be more effective in identifying cancerous areas in the body. The study will involve imaging tests, such as PET/CT scans, to see how the cancer responds to the treatments.

The study aims to gather information on the number of cancerous areas that show up with each treatment and how accurately these treatments can detect cancer. This information could be important for improving the way metastatic prostate cancer is diagnosed and monitored in the future. The study is expected to continue until the end of 2025, with recruitment starting in early 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing an informed consent form. This follows the receipt of written information about the study.
Eligibility includes being a man aged 50-85 years with confirmed prostate cancer and at least one distant metastasis detected through imaging techniques such as CT, MRI, bone scintigraphy, or SPECT.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the expression of prostate-specific membrane antigen (PSMA) and fibroblast activation-protein (FAP) in metastatic prostate cancer.
Step 3
Medication administration
The study involves the administration of two solutions for injection: [18F]FAPI-74 and 18F-DCFPyL. Both are given intravenously.
These medications are used to detect metastases through PET/CT imaging.
Step 4
Imaging procedures
PET/CT scans are performed to detect metastases. The scans use the administered solutions to highlight areas of interest.
The goal is to compare the effectiveness of 18F-FAPI-74 and 18F-DCFPyL in identifying metastases.
Step 5
Data collection and analysis
Data is collected on the proportion of PSMA- and/or FAPI-positive metastases and the number of metastases detected.
The sensitivity, specificity, accuracy, and other statistical measures of the imaging techniques are evaluated.
Step 6
Completion of participation
The study is estimated to conclude by December 31, 2025. Participation ends after all required data is collected and analyzed.

Who can join the trial?

6 criteria

Men with prostate cancer confirmed by a tissue sample test.
Age between 50 and 85 years at the start of the study.
Have a WHO performance score of 0 to 2, which is a way to measure how well a person can perform daily activities. A score of 0 means fully active, while 2 means unable to work but able to do most self-care.
Have at least one cancer spread (metastasis) found through imaging tests like CT, MRI, bone scan, or SPECT. These are different types of scans that help doctors see inside the body.
All previous treatments for prostate cancer are allowed, meaning it doesn't matter what treatments you have had before.
Must sign a consent form after being given written information about the study, showing that you agree to participate.

Who cannot join the trial?

3 criteria

Patients who do not have prostate cancer cannot participate. Prostate cancer is a type of cancer that occurs in the prostate, a small gland in men that produces seminal fluid.
Only male patients can participate. Female patients are not eligible.
Patients who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests.

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Verified sites

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Turku University Hospital
Turku, Finland

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Investigated drugs

PSMA
is a therapy used in this trial to target prostate-specific membrane antigen, which is a protein found on the surface of prostate cancer cells. This therapy helps in identifying and treating cancerous lesions by binding to the PSMA protein, allowing for precise targeting of cancer cells in metastatic prostate cancer.
FAPI
is another therapy involved in the trial, focusing on fibroblast activation-protein. This protein is associated with cancer-associated fibroblasts, which are present in the tumor environment. FAPI therapy aims to target these fibroblasts, potentially disrupting the tumor's support system and aiding in the treatment of metastatic prostate cancer.

What is already known about the treatment

PSMA-targeted therapy
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic prostate cancer. It is designed to target prostate-specific membrane antigen (PSMA), a protein commonly found on prostate cancer cells, allowing for precise delivery of therapeutic agents. The main therapeutic indication is prostate cancer, specifically in its metastatic form. PSMA-targeted therapy works by binding to the PSMA protein on cancer cells, which may help in delivering radioactive substances or drugs directly to the tumor, minimizing damage to healthy tissues. It falls under the pharmacological classification of targeted cancer therapies.
FAP-targeted therapy
Administered intravenously, this medication is under investigation in clinical trials for its potential use in treating metastatic prostate cancer. It targets fibroblast activation protein (FAP), which is often present in the tumor microenvironment, particularly in cancer-associated fibroblasts. The primary therapeutic indication is metastatic prostate cancer. FAP-targeted therapy operates by binding to FAP, potentially disrupting the supportive environment that tumors need to grow and spread. It is classified as a targeted cancer therapy, focusing on the tumor stroma rather than the cancer cells themselves.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The growth of cancer cells can lead to symptoms like difficulty urinating, blood in urine, or pelvic discomfort. In some cases, prostate cancer grows slowly and may not cause significant symptoms for many years. However, in other cases, it can grow quickly and require more immediate attention.