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Study of Lutetium (177Lu) Vipivotide Tetraxetan for Patients with High-Risk Prostate Cancer After Radiation and Hormone Therapy

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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, a disease that affects the prostate gland in men. The treatment being tested is called Pluvicto, which is a solution for injection or infusion containing the active substance lutetium (177Lu) vipivotide tetraxetan. This treatment is being explored as an additional therapy for patients who have already undergone radical treatment, including teleradiotherapy and hormone therapy, for high and very high-risk prostate cancer.

The purpose of the study is to assess the effectiveness of this treatment in preventing the return of cancer, known as biochemical progression. Participants will receive the treatment and be monitored over time to see if their prostate-specific antigen (PSA) levels, a marker used to track prostate cancer, increase. The study will also look at how long patients remain free from cancer progression and any side effects they may experience.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the status of their cancer. The study aims to provide valuable information on whether Pluvicto can help improve outcomes for patients with high-risk prostate cancer after they have completed their initial treatments.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of high-risk or very-high-risk prostate cancer.
Consent is required for participation, and a written informed consent form must be signed.
Step 2
Initial assessment
An initial assessment is conducted to ensure no signs of cancer spread, using imaging tests such as CT or MRI and a PET/CT scan.
Blood tests are performed to confirm adequate organ function and testosterone levels.
Step 3
Treatment administration
The treatment involves the administration of Pluvicto, a solution containing lutetium (177Lu) vipivotide tetraxetan, through an intravenous (IV) infusion.
The dosage and frequency of administration are determined by the study protocol and medical team.
Step 4
Monitoring and follow-up
Regular follow-up appointments are scheduled to monitor health status and assess any side effects.
Blood tests are conducted to measure prostate-specific antigen (PSA) levels and evaluate treatment effectiveness.
Step 5
End of treatment evaluation
At the end of the treatment period, a comprehensive evaluation is performed to assess the biochemical progression and overall health.
The study aims to measure the time from the end of treatment to any progression or need for additional therapy.

Who can join the trial?

13 criteria

The patient must have **prostate cancer** that is considered high-risk or very-high-risk. This is determined by specific medical criteria, such as the stage of cancer, certain test results, and biopsy findings.
If the patient is a man who can have children, he must agree to use a **double barrier contraception method**. This means using two forms of birth control to prevent pregnancy.
The patient must have completed a type of cancer treatment called **teleradiotherapy**, which is a form of radiation therapy.
The treatment mentioned above must have been completed within 3 months before joining the study.
The patient must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.
The patient must have an **ECOG performance status** of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
The patient must be over 18 years old.
The patient must show no signs of cancer spreading to other parts of the body within 28 days before joining the study. This must be confirmed by specific imaging tests like CT, MR, or PET/CT scans.
The patient must have a **castrate testosterone level**, meaning their testosterone level is below a certain threshold (less than 50 ng/dl or 1.7 nmol/L).
The patient must have adequate function of main organs, which includes:
**Bone marrow**: Enough white blood cells (neutrophils > 1500x10⁹/L), platelets (> 100,000x10⁹/L), and hemoglobin (> 9 g/dL).
**Liver**: Bilirubin levels less than twice the normal limit (or less than five times in patients with Gilbert's syndrome) and aminotransferase levels less than three times the normal limit.
**Kidneys**: An estimated glomerular filtration rate (eGFR) greater than 50 ml/min and albumin levels greater than 2.5 mg/ml.

Who cannot join the trial?

4 criteria

Only male participants are allowed. Female participants cannot join the study.
Participants must be within certain age ranges. If you are not in the specified age group, you cannot participate.
Participants must have a diagnosis of prostate cancer. If you do not have this condition, you cannot join the study.
The study does not include individuals considered part of a vulnerable population. This means people who might need special protection or care are not eligible.

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Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Warsaw, Poland

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Investigated drugs

177Lu-PSMA
is a type of targeted radiation therapy used in this trial. It is designed to deliver radiation directly to prostate cancer cells by attaching to a molecule called PSMA, which is commonly found on the surface of these cancer cells. This helps to destroy the cancer cells while minimizing damage to surrounding healthy tissue.
Hormone Therapy
is used to lower the levels of male hormones, such as testosterone, which can fuel the growth of prostate cancer cells. By reducing these hormone levels, the therapy aims to slow down or stop the growth of the cancer.
Locoregional Teleradiotherapy
is a form of external beam radiation therapy that targets the prostate and surrounding areas. It uses high-energy rays to kill cancer cells and shrink tumors, helping to control the disease locally.

Lutetium (177Lu) Vipivotide Tetraxetan

What is already known about the treatment

177Lu-PSMA – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating prostate cancer. It is not yet widely used in standard medical practice but shows promise in medical literature as a potential treatment option. The main therapeutic indication for 177Lu-PSMA is prostate cancer, particularly in patients who have undergone radical treatment with locoregional teleradiotherapy and hormone therapy. At the molecular level, it works by targeting the prostate-specific membrane antigen (PSMA) on cancer cells, delivering a radioactive payload that helps to destroy these cells. It is classified pharmacologically as a radiopharmaceutical agent.

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 with urination, blood in the urine, or pelvic discomfort. The disease can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Monitoring involves tracking levels of prostate-specific antigen (PSA) in the blood, as increases can indicate progression. The progression is often assessed through imaging and other tests to determine the extent of the disease.