Not recruiting

Study on the Safety of Lutetium (177Lu) Zadavotide Guraxetan and Radium Ra 223 Dichloride for Patients with Bone-Metastatic 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 clinical trial is focused on studying a type of cancer called prostate cancer, specifically in patients whose cancer has spread to the bones and is sensitive to hormone treatment. The study will explore the use of two treatments: Lutetium Lu-177 PSMA I&T Injection and Xofigo, which is also known as Radium Ra 223 Dichloride. These treatments are given as injections and are part of a group of therapies known as radioligand therapies, which use radioactive substances to target and treat cancer cells.

The purpose of the study is to assess how safe and feasible it is to use these treatments alternately in patients who have already received curative therapy, such as surgery or radiation, for their prostate cancer. Participants will receive these treatments in a specific sequence, and the study will monitor how well they tolerate the treatments and any side effects they may experience. The study will also look at how these treatments affect the patients' quality of life and the progression of their cancer over time.

Throughout the study, participants will undergo regular assessments to check their health and the status of their cancer. This includes monitoring their prostate-specific antigen (PSA) levels, which is a marker used to track prostate cancer, and using imaging tests like PET/CT scans to see how the cancer responds to the treatment. The study aims to provide valuable information on the potential benefits and risks of using these radioligand therapies in treating prostate cancer that has spread to the bones.

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 assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and current health status.
Blood tests will be performed to check white blood cells, platelet count, hemoglobin levels, and kidney function.
A scan will be conducted to identify prostate-specific membrane antigen (PSMA) expressing metastases.
Step 2
Treatment cycle 1
The first treatment involves receiving an injection of Lutetium Lu-177 PSMA I&T. This is a radioligand therapy designed to target cancer cells.
The injection is administered as a solution and is given through a vein.
Step 3
Monitoring and assessment
After the first treatment, regular monitoring will occur to assess health and any side effects. This includes blood tests and health questionnaires.
Health-related quality of life will be evaluated using specific questionnaires every two weeks.
Step 4
Treatment cycle 2
The second treatment involves receiving an injection of Radium Ra 223 dichloride. This is another type of radioligand therapy aimed at treating bone metastases.
The injection is administered as a solution and is given through a vein.
Step 5
Ongoing monitoring
Continuous monitoring will be conducted to evaluate the safety and effectiveness of the treatments. This includes regular blood tests and imaging scans.
Patient-reported outcomes will be collected to assess any side effects, such as dry mouth, and overall health status.
Step 6
Final assessment
A final assessment will be conducted three months after the last treatment. This includes imaging scans to evaluate the response to treatment.
The study will also assess prostate-specific antigen (PSA) levels to determine the effectiveness of the treatment over time.

Who can join the trial?

16 criteria

Must have a histologically proven adenocarcinoma of the prostate. This means that a tissue sample from the prostate has been examined under a microscope and confirmed to be cancer.
Must have an ECOG performance status of 0-1. This is a scale used to assess how a patient's disease is progressing, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of more than 12 months.
Must meet certain laboratory values:
- White blood cells greater than 4.0 x 10⁹/l
- Platelet count greater than 150 x 10⁹/l
- Hemoglobin greater than 7.0 mmol/l
- MDRD-GFR (a measure of kidney function) greater than or equal to 60 ml/min
- Must have signed informed consent, meaning you agree to participate after being informed about the study.
- Must have had previous curative therapy with either a radical prostatectomy (surgical removal of the prostate) or external-beam radiotherapy (EBRT).
- Must have a biochemical recurrence, which means a rise in PSA (Prostate-Specific Antigen) levels:
  - PSA greater than 0.5 μg/l or PSA greater than 2.0 above the lowest level reached (nadir)
  - Must have a PSA-doubling time of less than 6 months. This means the time it takes for the PSA level to double is less than 6 months, with two consecutive rising PSA values measured at least 1 week apart.
  - Must have PSMA expressing metastases on an 18F-PSMA-PET-CT scan, which shows cancer spread to bones or lymph nodes, with at least 2 but no more than 5 bone metastases.
  - Local treatment for oligometastases (limited number of metastases) with radiotherapy or surgery is no longer an option, either due to previous treatment, the location of the metastases, or if the patient refuses these treatments.
  - Must not have had any prior hormonal therapy or taxane-based chemotherapy. This includes treatments like finasteride, dutasteride, bicalutamide, apalutamide, abiraterone, enzalutamide, darolutamide, docetaxel, or cabazitaxel.
  - Must have a testosterone level greater than 1.7 nmol/l at baseline within 4 weeks before starting therapy.
  - Must have a detectable lesion on the 18F-PSMA PET/CT scan with significant PSMA avidity, defined by a SUVmax (a measure of how much the cancer cells take up the tracer) greater than 15, at baseline within 4 weeks before starting therapy.

Who cannot join the trial?

3 criteria

Patients who do not have prostate cancer cannot participate.
Only male patients can participate.
Patients who are part of a vulnerable population cannot participate. This means people who might be at a higher risk of harm or exploitation.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands

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Investigated drugs

Radium-223
is a type of treatment that uses a small amount of radiation to target cancer cells in the bones. It works by delivering radiation directly to the areas where cancer has spread, helping to kill cancer cells and reduce pain. This therapy is specifically used for patients whose prostate cancer has spread to the bones.
177Lu-PSMA
is a therapy that combines a radioactive substance with a molecule that specifically targets prostate cancer cells. This treatment helps to deliver radiation directly to the cancer cells, minimizing damage to healthy tissues. It is used to treat prostate cancer that has spread to other parts of the body, particularly when the cancer is sensitive to hormones.

What is already known about the treatment

Radium-223
Radium-223 is administered as an injection into a vein, typically in a hospital or clinical setting. It is currently being studied for its effectiveness and safety in treating prostate cancer that has spread to the bones. The main therapeutic use of Radium-223 is to target and kill cancer cells in the bones, helping to relieve pain and improve quality of life. At the molecular level, Radium-223 mimics calcium and binds to bone, where it emits radiation that damages the DNA of nearby cancer cells, leading to their death. It is classified as a radiopharmaceutical, which is a type of drug that contains radioactive material.
Lutetium-177-PSMA
Lutetium-177-PSMA is given as an intravenous infusion, usually in a medical facility. It is being explored for its potential to treat prostate cancer that has metastasized to the bones. The primary therapeutic indication for Lutetium-177-PSMA is to target prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to them. On a molecular level, it binds to PSMA, a protein found in high amounts on prostate cancer cells, and releases radiation that destroys these cells. This medication falls under the category of radioligand therapy, which combines a radioactive substance with a molecule that specifically targets cancer cells.

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 disease can spread to nearby tissues or bones, known as metastasis, which can cause additional symptoms like bone pain. Hormone-sensitive prostate cancer responds to treatments that lower testosterone levels, which can slow the progression. Oligometastatic prostate cancer refers to a state where the cancer has spread to a limited number of sites outside the prostate.