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Study of [177Lu]Lu-PSMA-I&T Therapy for Patients with Oligometastatic Prostate Cancer Using Gozetotide and Stannous Oxide Combination

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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 treatment for prostate cancer, specifically in patients with a type called oligometastatic prostate cancer. This means the cancer has spread to a few other parts of the body. The treatment being tested is called [177Lu]Lu-PSMA-I&T, which is a type of radioligand therapy. Radioligand therapy uses a radioactive substance to target and kill cancer cells. The study aims to see how well this treatment works when given before surgery to remove the prostate, known as a radical prostatectomy.

Participants in the study will receive the treatment [177Lu]Lu-PSMA-I&T through an injection into a vein. The study will also use a special imaging technique called [68Ga]Ga-PSMA-11 PET to help diagnose and monitor the cancer. This imaging method helps doctors see where the cancer is located in the body. The study will observe how the cancer responds to the treatment and how it affects the participants' health over time.

The purpose of the study is to evaluate the effects of the treatment on the cancer and to ensure it is safe for patients. The study will monitor the participants' health and any side effects they may experience. The goal is to gather information that could help improve treatment options for patients with prostate cancer in the future.

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 is conducted to confirm eligibility. This includes a review of medical history and current health status.
Eligibility criteria include being between 18 and 75 years old, having a specific type of prostate cancer, and meeting certain health requirements such as adequate bone marrow and kidney function.
Step 2
Imaging procedure
A specialized imaging procedure using [68Ga]Ga-PSMA-11 PET is performed to diagnose the extent of prostate cancer. This helps in identifying the presence of metastases.
Step 3
Treatment administration
The treatment involves the administration of [177Lu]Lu-PSMAI&T radioligand therapy. This is given as an intravenous injection.
The specific product used is Locametz 25 micrograms kit for radiopharmaceutical preparation and TECEOS Trockenstechampullen.
The treatment is administered in a controlled setting to ensure safety and monitor any immediate reactions.
Step 4
Monitoring and follow-up
After the treatment, regular monitoring is conducted to assess the response to therapy. This includes evaluating PSA levels, imaging results, and overall health.
Follow-up appointments are scheduled to track progress and address any side effects or concerns.
Step 5
Surgical procedure
If the treatment is successful and the patient is deemed suitable, a surgical procedure known as radical prostatectomy may be performed to remove the prostate gland.
Step 6
Final evaluation
A final evaluation is conducted to assess the overall outcomes of the treatment and surgery. This includes reviewing oncological outcomes and any changes in cancer status.

Who can join the trial?

6 criteria

Patients must be adults between 18 and 75 years of age.
Patients must have a type of prostate cancer called **oligometastatic prostate cancer**. This means the cancer has spread to a few other places in the body. It is diagnosed using a special imaging test called **[68Ga]Ga-PSMA-11**. The cancer can be in the bones (up to 5 spots) or in the lungs (up to 3 spots).
Patients must have an **ECOG Performance Status** of 0-1. This is a scale that measures how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
Patients must have enough healthy blood cells. This means having a **white blood cell count** of at least 1.5 x 10⁹ per liter, **platelets** of at least 100 x 10⁹ per liter, and **hemoglobin** of at least 9 grams per deciliter.
Patients must have good kidney function. This is measured by a test called **eGFR**, which should be at least 50 mL/min/1.73m². They should also have an **albumin level** of at least 2.5 grams per deciliter. Albumin is a protein in the blood.
Patients must be able to understand and sign an **Informed Consent Form**, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with 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.
Patients who are not male cannot participate. This study is only for male patients.
Patients who are not within the specified age range cannot participate. The study is for certain age groups, but the exact ages are not specified here.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.

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Verified sites

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

[177Lu]Lu-PSMAI&T
is a type of radioligand therapy used in this clinical trial. It is designed to target prostate-specific membrane antigen (PSMA) in prostate cancer cells. This therapy involves a radioactive substance that binds to PSMA, allowing it to deliver radiation directly to the cancer cells, potentially reducing the size of tumors and limiting the spread of cancer.
[68Ga]Ga-PSMA-11
is a diagnostic imaging agent used in this study. It helps in identifying prostate cancer cells by binding to PSMA, which is present on the surface of these cells. This agent is used in PET imaging to detect the presence and extent of prostate cancer, aiding in the diagnosis and treatment planning for patients.

What is already known about the treatment

[177Lu]Lu-PSMAI&T – This medication is administered as a radioligand therapy, typically through intravenous injection. It is currently being studied in clinical trials for its effectiveness in treating prostate cancer, specifically in patients with oligometastatic prostate cancer. The main therapeutic indication is prostate carcinoma. The mechanism of action involves targeting 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 used in targeted cancer therapy.

Investigated diseases

Prostate Carcinoma – Prostate carcinoma, commonly known as prostate cancer, is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This type of cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties in urination, blood in the urine, or pelvic discomfort. In some cases, it may spread to other parts of the body, such as the bones or lymph nodes. The progression and symptoms can vary widely among individuals.