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Study of PSMA PET imaging versus standard imaging to guide radiation therapy in patients with intermediate or high-risk prostate cancer

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 study focuses on patients with intermediate-risk or high-risk prostate cancer who are planned to receive radiotherapy. The research evaluates the effectiveness of using a special imaging technique called PSMA PET (Prostate-Specific Membrane Antigen Positron Emission Tomography) to guide radiation treatment planning. The study uses Locametz, which contains the active substance gozetotide, as an imaging agent that is given through an intravenous injection.

The purpose of the study is to compare the outcomes of radiation treatment when planned using PSMA PET imaging versus standard imaging methods. The study involves two groups of patients - one group will receive radiation therapy planned using conventional imaging, while the other group will have their treatment planned using PSMA PET scans. Each participant will receive a single dose of the imaging agent before their radiation treatment planning.

During the study, patients will be monitored for several years to track their response to treatment and any changes in their cancer status. The monitoring includes regular check-ups and various tests to assess how well the treatment is working. The study medication (Locametz) is already approved for use in medical imaging and will be given as a single dose of up to 259 MBq (a measure of radioactivity).

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
Initial qualification
You will be evaluated for participation if you are a male, 18 years or older, with confirmed prostate cancer
Your cancer must be classified as intermediate- to high-risk, which means having at least one of these factors: PSA>10ng/mL, advanced tumor stage, or specific risk scores
You need to be physically able to perform daily activities without assistance (ECOG status 0-1)
Step 2
Study group assignment
You will be randomly assigned to one of two groups
One group will receive standard imaging before radiation therapy
The other group will receive PSMA PET imaging (a special type of scan) before radiation therapy
Step 3
Imaging procedure
If assigned to the PSMA PET group, you will receive Locametz, a diagnostic medicine given through an intravenous injection
The imaging results will be used to plan your radiation treatment
Step 4
Radiation therapy
You will undergo radiation therapy based on your imaging results
The treatment plan will be customized according to your specific situation
Step 5
Follow-up period
Your progress will be monitored through regular check-ups
Blood tests will be performed to measure PSA levels (a protein that can indicate cancer activity)
Additional imaging may be performed if needed
The study will continue until 2033
Step 6
Safety considerations
You must use appropriate contraception during the study
After receiving the study medication, you should avoid sperm donation for 24 hours
Any side effects will be monitored and documented throughout the study

Who can join the trial?

13 criteria

Must be male
Must be 18 years or older
Must agree not to donate sperm for 24 hours after receiving study treatment
Must sign an informed consent form showing understanding of the study purpose and procedures
Must have confirmed prostate adenocarcinoma (a type of prostate cancer) through tissue examination
Must have intermediate to high-risk disease with at least one of these conditions:
- PSA blood test above 10 ng/mL
- Cancer stage 2b or higher
- Gleason score 7 or higher (a measure of cancer aggressiveness)
- Decipher Score 0.45 or higher (a genetic test that measures cancer risk)
- Must be willing to undergo radiation therapy
- Must be willing to have PSMA PET scan results used in radiation therapy planning if assigned to that study group (PSMA PET is a special type of imaging scan)
- Must have good physical function status (ECOG grade 0 or 1, meaning able to carry out all or most daily activities)
- Must agree to use condoms during sexual activity while receiving study treatment and for 24 hours afterward

Who cannot join the trial?

12 criteria

Previous treatment with radiation therapy (a treatment that uses high doses of radiation to destroy cancer cells) to the prostate or pelvic area
Previous surgery of the prostate
Known allergies or hypersensitivity to substances used in PET imaging (a type of medical scan that helps detect cancer)
Presence of metal implants or devices that would interfere with imaging procedures
Unable to lie flat for the required imaging procedures
Any condition that makes it impossible to deliver radiation therapy safely
Participation in other clinical trials that could interfere with this study
Female patients (study is only for male patients)
Age under 18 years
Presence of cancer that has spread beyond the prostate to other parts of the body
Serious medical conditions that could interfere with study participation or patient safety
Unable to provide informed consent

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Verified sites

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Universitaetsklinikum Essen AöR
Verified
Essen, Germany

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Investigated drugs

Based on the provided trial information, the main imaging therapies involved are: PSMA PET (Prostate-Specific Membrane Antigen Positron Emission Tomography) is an advanced imaging technique that uses a special radioactive tracer to create detailed pictures of prostate cancer cells throughout the body. This imaging method is particularly effective at detecting prostate cancer, even in its early stages. Standard-of-care imaging includes conventional imaging techniques typically used for prostate cancer detection and monitoring. These may include CT scans (Computed Tomography) and bone scans, which are traditional methods used to evaluate prostate cancer spread and plan radiation treatment. Radiation Therapy (RT) is used as the main treatment in this trial, with its planning and delivery being guided by either PSMA PET or standard imaging results. This therapy uses high-energy radiation to target and destroy cancer cells in the prostate.

Gozetotide

What is already known about the treatment

68Ga-PSMA – A radioactive diagnostic imaging agent administered intravenously for PET (Positron Emission Tomography) scanning, specifically designed to detect prostate cancer cells. This radiopharmaceutical works by binding to a specific protein called Prostate-Specific Membrane Antigen (PSMA), which is typically overexpressed in prostate cancer cells, allowing for precise visualization of cancer spread. It belongs to the class of diagnostic radiopharmaceuticals and is particularly useful in identifying the location and extent of prostate cancer in intermediate and high-risk patients before radiation therapy, helping to guide treatment planning and improve therapeutic outcomes.

Investigated diseases

Prostate Cancer - A disease that develops in the prostate gland, which is part of the male reproductive system. It typically begins when normal prostate cells start to grow uncontrollably. The cancer usually develops slowly and initially stays within the prostate gland, where it may not cause serious harm. As the disease progresses, cancer cells may spread beyond the prostate into surrounding tissues. In its early stages, prostate cancer often causes no noticeable symptoms. The condition is more common in older men and tends to grow more slowly compared to many other types of cancer.