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Study Comparing Conventional Radiotherapy and PSMA-PET/CT Targeted Treatment with 18F-PSMA-1007 and Gozetotide for Prostate Cancer Recurrence After Surgery

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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 patients who have experienced a biochemical recurrence after undergoing surgery for prostate cancer. Biochemical recurrence refers to the return of signs of prostate cancer, indicated by rising levels of a protein called PSA, after initial treatment. The study aims to compare two different approaches to treating this condition: conventional "salvage" radiotherapy and a more personalized treatment based on results from a specialized imaging test called PSMA PET/CT. This imaging test helps to identify specific areas where cancer may have returned, allowing for targeted treatment.

Participants in the study will receive either the standard radiotherapy or the individualized treatment. The individualized treatment involves using a special solution called 18F-PSMA-1007, which is injected into the body to help highlight cancer cells during the PSMA PET/CT scan. Another product used in the study is the Locametz 25 micrograms kit for radiopharmaceutical preparation, which contains a substance called gozetotide. Both treatments are administered through an injection into a vein.

The purpose of the study is to determine which treatment approach is more effective in preventing the progression of prostate cancer, as measured by PSA levels. Participants will be monitored over time to assess their response to treatment, including how long it takes for the cancer to spread, their overall survival, and their quality of life. The study will also track the time until any additional treatments are needed. This research is expected to provide valuable insights into the best ways to manage prostate cancer recurrence after surgery.

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
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have had a biochemical recurrence after prostate cancer surgery, with a PSA level greater than 0.2 and less than 2.0 ng/mL, measured twice.
A multidisciplinary conference decision will confirm the offer of salvage radiotherapy.
Step 3
Randomization
You will be randomly assigned to one of two treatment groups: conventional 'salvage' radiotherapy or individualized treatment based on PSMA PET/CT assessments.
Step 4
Treatment administration
If assigned to the individualized treatment group, you will receive a solution for injection called 18F-PSMA-1007 or Locametz 25 micrograms kit for radiopharmaceutical preparation. This is administered through an intravenous route.
The frequency and duration of administration will be determined by the study protocol and your specific treatment plan.
Step 5
Follow-up assessments
After completing the treatment, follow-up assessments will be conducted to monitor your PSA levels. The primary goal is to achieve PSA progression-free survival.
These assessments will help determine if there is a response to the treatment or if there is any progression.
Step 6
Quality of life evaluations
You will be asked to complete a quality of life questionnaire called PSMA-PROM at baseline and at 6, 12, 36, and 60 months after completing the treatment.
This questionnaire is designed to assess your well-being and any changes over time.

Who can join the trial?

5 criteria

Must be a male patient.
Previously treated for prostate cancer with surgery called radical prostatectomy.
Experiencing a biochemical recurrence (BCR), which means the prostate-specific antigen (PSA) level is between 0.2 and 2.0 ng/mL and is rising, confirmed by two tests.
A team of doctors, known as a multidisciplinary conference (MDK), has decided to offer the patient a treatment called salvage radiotherapy (SRT).
Must have signed an Informed Consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients who have not experienced a biochemical recurrence after prostate cancer surgery. (Biochemical recurrence means that there is a rise in the prostate-specific antigen (PSA) level after treatment, indicating that prostate cancer might have returned.)
Patients who are female. (This study is only for male patients.)
Patients who are considered part of a vulnerable population. (Vulnerable populations include groups like children, pregnant women, or those unable to give consent.)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Karolinska University Hospital
Verified
Solna, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

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Investigated drugs

PSMA-PET/CT Targeted Treatment is a specialized therapy used in this clinical trial. It involves using a type of imaging called PSMA-PET/CT to identify specific areas in the body where prostate cancer might have returned after surgery. Once these areas are identified, the treatment is targeted directly at them, which can help in managing the cancer more effectively. This approach is personalized, meaning it is tailored to the specific needs of each patient based on the imaging results. The goal is to improve the chances of stopping the cancer from progressing.

Gozetotide

What is already known about the treatment

PSMA-PET/CT targeted treatment – This treatment is administered through imaging technology that combines Positron Emission Tomography (PET) and Computed Tomography (CT) to target prostate-specific membrane antigen (PSMA) in patients. It is currently being studied in clinical trials to assess its effectiveness compared to traditional radiotherapy for patients experiencing a biochemical recurrence of prostate cancer after surgery. The main therapeutic indication is to improve progression-free survival by precisely targeting cancer cells that express PSMA. At the molecular level, this approach works by using a radioactive tracer that binds to PSMA, allowing for precise imaging and targeted treatment of cancerous tissues. This treatment falls under the pharmacological classification of targeted radiotherapy.

Investigated diseases

Biochemical recurrence after prostate cancer surgery – This condition occurs when there is a rise in the prostate-specific antigen (PSA) levels following surgery for prostate cancer, indicating that cancer cells may still be present. After the prostate gland is removed, PSA levels should ideally be undetectable or very low. However, if PSA levels begin to increase, it suggests that prostate cancer cells might have survived the surgery and are active. The progression of this condition is monitored by measuring PSA levels over time. A consistent rise in PSA levels can indicate the need for further treatment to manage the recurrence. The condition does not always lead to symptoms, and its progression can vary among individuals.