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Study on the Use of 18F-PSMA-1007, Hyoscine Butylbromide, and Gadoteric Acid in Imaging for Patients with High-Risk Prostate Cancer

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What is this trial about?

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

This clinical trial focuses on studying prostate cancer, specifically high-risk cases. The study will use a special imaging technique called PSMA-PET and another method known as mpMRI to identify and map out important areas within the prostate that are affected by cancer. The main goal is to see how accurate these imaging methods are in detecting the most significant cancerous regions compared to traditional tissue examination.

During the trial, participants will receive an injection of a substance called 18F-PSMA-1007, which helps highlight cancer cells during the PSMA-PET scan. Additionally, other substances like Buscopan, Dotarem, and Glucagon may be used to assist in the imaging process. These substances are administered through injections and are commonly used in medical imaging to improve the quality of the scans.

The study will monitor participants for a short period after the imaging procedures to ensure their safety and to record any side effects. The trial aims to improve the understanding of how these imaging techniques can be used to better plan treatments for prostate cancer, potentially leading to more effective management of the disease. Participants will not be given a placebo during this study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of high-risk prostate cancer and ensuring that a PSMA-PET/CT scan has been performed as part of your clinical management.
Eligibility criteria include being over 18 years old, having a Gleason score of 8 or higher, a PSA level between 20-49 ng/ml, or a clinical stage of cT3 or higher. A written consent to participate is required.
Step 2
Imaging procedures
The study involves two main imaging procedures: PSMA-PET and mpMRI. These are used to identify and outline significant areas within the prostate.
PSMA-PET involves the use of a radioactive substance called 18F-PSMA-1007, administered through an intravenous injection. This helps in visualizing prostate cancer cells.
Step 3
Administration of medications
During the imaging procedures, additional medications may be administered to enhance image quality. These include hyoscine butylbromide and gadoteric acid, both given as solutions for injection.
Hyoscine butylbromide is administered subcutaneously, while gadoteric acid is given intravenously. Glucagon may also be administered via intramuscular injection to reduce bowel movement during imaging.
Step 4
Surgical procedure
If eligible, a radical prostatectomy is planned as part of the treatment. This surgical procedure involves the removal of the prostate gland and some surrounding tissue.
The imaging results from PSMA-PET and mpMRI are compared with the histopathological findings from the surgery to evaluate the accuracy of these imaging techniques.
Step 5
Follow-up and evaluation
After the surgical procedure, follow-up assessments are conducted to monitor recovery and evaluate outcomes such as disease-free survival and time to relapse.
Adverse events are monitored for up to one week after treatment to ensure safety and address any concerns that may arise.

Who can join the trial?

9 criteria

The patient must have a confirmed diagnosis of **high-risk prostate cancer**. This means the cancer is more likely to grow and spread quickly.
The patient should be planning to undergo a **radical prostatectomy**, which is a surgery to remove the prostate gland.
A **PSMA-PET/CT scan** must have been done as part of the patient's current cancer care. This is a special imaging test that helps to see cancer cells in the body.
It must be at least **4 weeks since the last biopsy** of the prostate. A biopsy is a procedure where a small sample of tissue is taken to check for cancer.
The patient must meet one or more of the following conditions:
- **cT3 stage** or a high suspicion of cancer growing outside the prostate on an **mpMRI**. An mpMRI is a detailed imaging test of the prostate.
- A **Gleason score of 8 or higher**. This score indicates how aggressive the cancer is.
- A **PSA level between 20-49 ng/ml**. PSA is a protein made by the prostate, and higher levels can indicate cancer.
- The patient must be **over 18 years old**.
- The patient must have given **written consent** to participate in the trial, meaning they agree to join the study after understanding what it involves.

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 are eligible, so female patients cannot participate.
Patients who are considered part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible.

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Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

PSMA-PET
is a type of imaging test used in this trial to help identify and map out areas within the prostate that may have cancer. It uses a special tracer that targets prostate-specific membrane antigen (PSMA), which is often found in higher amounts on prostate cancer cells. This helps doctors see where the cancer is located and how much of it there might be.
mpMRI
, or multiparametric MRI, is another imaging technique used in the trial. It combines different types of MRI scans to provide a detailed picture of the prostate. This helps in identifying areas that might be cancerous and in understanding the extent of the disease within the prostate.

What is already known about the treatment

PSMA-PET
This diagnostic tool is administered through an intravenous injection and is used in imaging to detect prostate cancer. It is currently being evaluated in clinical trials to assess its accuracy in identifying significant cancerous lesions within the prostate. The main therapeutic indication is for the detection and staging of prostate cancer. At the molecular level, PSMA-PET works by targeting the Prostate-Specific Membrane Antigen, which is often overexpressed in prostate cancer cells, allowing for precise imaging. It falls under the pharmacological classification of radiopharmaceuticals used in nuclear medicine imaging.
mpMRI
This imaging technique is non-invasive and involves the use of magnetic resonance imaging to visualize prostate cancer. It is being studied in clinical trials to determine its effectiveness in accurately identifying and mapping significant cancerous areas within the prostate. The primary therapeutic indication is for the diagnosis and assessment of prostate cancer. The mechanism of action involves the use of magnetic fields and radio waves to produce detailed images of the prostate and surrounding tissues. It is classified under diagnostic imaging techniques in radiology.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can lead to difficulties in urination, blood in urine, or pelvic discomfort. The cancer can spread to nearby tissues or other parts of the body, such as bones or lymph nodes. The progression can vary greatly among individuals, with some experiencing rapid growth and others having a more indolent course. Monitoring and understanding the specific characteristics of the cancer are crucial for managing its progression.