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Study Comparing 177Lu-PSMA-I&T with Apalutamide, Enzalutamide, and Abiraterone for Patients with Metastatic Hormone-Sensitive Prostate Cancer

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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 treatments for metastatic hormone-sensitive prostate cancer, a type of cancer that has spread beyond the prostate gland and still responds to hormone therapy. The study will compare the effectiveness of a new treatment called [177Lu]PSMA-I&T, which is a solution for injection, against existing hormone therapies including Apalutamide, Enzalutamide (also known as MDV3100), and Abiraterone Acetate. These hormone therapies are taken as oral tablets. The main goal of the study is to see which treatment helps patients live longer without the cancer getting worse.

Participants in the study will be randomly assigned to receive either the new treatment or one of the existing hormone therapies. The study will monitor the participants over a period to assess how well the treatments work in preventing the cancer from progressing. The study will also look at the overall survival of the participants, which means the time from the start of treatment until death from any cause. Additionally, the study will evaluate the safety and quality of life of the participants using specific questionnaires.

Other medications used in the study include Betamethasone, Dexamethasone, Metoclopramide Hydrochloride, and Ondansetron, which are antiemetics, meaning they help prevent nausea and vomiting. These medications are also taken as oral tablets. The study aims to provide valuable information on the best treatment options for patients with metastatic hormone-sensitive prostate cancer, focusing on improving progression-free survival, which is the time during and after treatment that a patient lives with the disease without it getting worse.

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, you will be randomly assigned to one of two treatment groups. This means you will either receive the experimental treatment or the standard treatment. The assignment is random, like flipping a coin, to ensure fairness.
Step 2
Treatment group assignment
If you are assigned to the experimental group, you will receive **177Lu-PSMA-I&T** as a solution for injection. This treatment is administered at specific intervals as determined by the study protocol.
If you are assigned to the standard treatment group, you will receive one of the following oral medications: **apalutamide**, **enzalutamide**, or **abiraterone acetate**. These medications are taken in the form of film-coated tablets. The dosage and frequency will be provided by the study team.
Step 3
Regular health assessments
Throughout the study, you will undergo regular health assessments. These assessments are designed to monitor your health and the effects of the treatment. They may include physical exams, blood tests, and imaging scans.
The study team will inform you of the schedule for these assessments and any specific preparations required.
Step 4
Monitoring and reporting
You will be asked to report any side effects or changes in your health to the study team. This information is crucial for ensuring your safety and the success of the study.
The study team will provide you with contact information and instructions on how to report any issues.
Step 5
End of treatment
At the end of the treatment period, you will have a final set of assessments to evaluate your response to the treatment. This will help determine the effectiveness of the treatment and any long-term effects.
The study team will discuss the results with you and provide guidance on any further steps or follow-up care needed.

Who can join the trial?

12 criteria

Must have a confirmed diagnosis of prostate cancer.
Must have metastatic HSPC (hormone-sensitive prostate cancer) with disease that can be measured or evaluated.
Must show evidence of PSMA-positive disease on a specific type of scan called a PET/CT scan.
If you have a female partner who can become pregnant, you must use effective birth control, like a condom, during the study and for 3 months after the last dose.
Must be at least 18 years old.
Must have an ECOG performance status of 0 to 2, which means you are fully active or have some limitations but can still take care of yourself.
Must have an estimated survival time of at least 3 months.
Must not be eligible for a treatment called triple therapy with Docetaxel.
Must have a white blood cell count of at least 2000/mm³, neutrophils (a type of white blood cell) of at least 1500/mm³, and platelets (cells that help with blood clotting) of at least 100,000/mm³.
Must have satisfactory liver function, with bilirubin and transaminases levels no more than 1.5 times the normal limit.
Must have satisfactory kidney function, with serum creatinine less than 1.5 times the normal limit. If creatinine is between 1.0 and 1.5 times the normal limit, creatinine clearance will be calculated, and it must be more than 60 mL/min.
Must provide informed consent by signing a document that explains the study and agrees to participate.

Who cannot join the trial?

3 criteria

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

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Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

177Lu-PSMA-I&T
is a type of targeted therapy used in the treatment of prostate cancer. It works by delivering radiation directly to the cancer cells. This medication is designed to attach to a specific protein found on the surface of prostate cancer cells, allowing it to deliver radiation precisely to the tumor, which helps to kill the cancer cells while minimizing damage to the surrounding healthy tissue.
Apalutamide
is a medication used to treat prostate cancer. It works by blocking the action of male hormones, like testosterone, which can promote the growth of cancer cells. By reducing the effect of these hormones, Apalutamide helps to slow down or stop the growth of cancer cells.
Enzalutamide
is another medication used in the treatment of prostate cancer. Similar to Apalutamide, it works by blocking the effects of male hormones that can stimulate the growth of cancer cells. This helps to slow the progression of the disease and manage its symptoms.
Abiraterone Acetate
is a medication that treats prostate cancer by reducing the production of male hormones in the body. It works by blocking an enzyme that is involved in the production of these hormones, which can help to slow the growth of cancer cells and improve patient outcomes.

What is already known about the treatment

177Lu-PSMA-I&T
This medication is administered through an injection and is currently being studied in clinical trials for its effectiveness in treating prostate cancer. It is a radiopharmaceutical, which means it uses a radioactive substance to target and kill cancer cells. The main therapeutic indication is for metastatic hormone-sensitive prostate cancer, where it aims to improve progression-free survival. At the molecular level, it binds to a protein called PSMA on prostate cancer cells, delivering radiation directly to the tumor and minimizing damage to surrounding healthy tissue.
Apalutamide
This medication is taken orally in the form of tablets and is used in the treatment of prostate cancer. It is an androgen receptor inhibitor, which means it blocks the action of male hormones that can promote the growth of cancer cells. The main therapeutic indication is for metastatic hormone-sensitive prostate cancer, aiming to delay disease progression. By preventing these hormones from binding to their receptors, it helps slow down or stop the growth of cancer cells.
Enzalutamide
Administered orally as a capsule, this medication is used to treat prostate cancer by inhibiting androgen receptors. It is specifically indicated for metastatic hormone-sensitive prostate cancer, with the goal of improving progression-free survival. Enzalutamide works by blocking the effects of male hormones that can stimulate cancer growth, thereby slowing down the progression of the disease.
Abiraterone Acetate
This medication is taken orally in tablet form and is used to treat prostate cancer. It works by inhibiting an enzyme called CYP17, which is involved in the production of male hormones that can fuel cancer growth. The main therapeutic indication is for metastatic hormone-sensitive prostate cancer, aiming to improve progression-free survival by reducing hormone levels and slowing cancer progression.

Investigated diseases

Prostate cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The progression can be monitored through various indicators, including radiographic imaging and prostate-specific antigen (PSA) levels. Symptoms may include difficulty urinating, pelvic discomfort, and bone pain if the cancer has spread. The rate of progression can vary significantly among individuals.