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A study to evaluate the effects of lutetium (177lu) vipivotide tetraxetan in patients with metastatic hormone sensitive prostate cancer receiving androgen deprivation therapy.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Metastatic hormone sensitive prostate cancer, a type of prostate cancer that has spread to other parts of the body and is still responsive to hormone treatments. Participants in the study are currently receiving androgen deprivation therapy, which is a method used to lower the levels of male hormones to help slow the growth of cancer cells. The purpose of the study is to determine if adding new treatments to the standard care can improve survival and cancer outcomes.

One of the treatments being tested is lutetium (177lu) vipivotide tetraxetan, which is administered as a solution for injection or infusion directly into a vein. This medication is a type of radiopharmaceutical, meaning it contains a small amount of radiation designed to target cancer cells. The study follows a specific design to compare different treatment approaches against standard care to see which options are most effective for patients.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
Participation in the trial begins upon randomization, which is the process of being assigned to a specific treatment group by chance.
Step 2
Administration of treatment
The dose of pluvicto is 7.4 GBq (gigabecquerel, a unit used to measure radioactivity).
Step 3
Monitoring and evaluation
Additional monitoring is conducted to assess failure-free survival, radiographic progression-free survival (the time during which cancer does not appear to grow on scans), prostate cancer specific survival, safety, toxicity, compliance, quality of life, and resource use.

Who can join the trial?

13 criteria

You must be at least 18 years old.
You must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of cancer that starts in the prostate gland.
Medical imaging, such as a CT scan, MRI, or PET scan, must confirm that the cancer has spread to other parts of the body.
The cancer must have spread to at least one of the following areas: the bones, lymph nodes (small glands in the immune system), or visceral organs (internal organs like the liver or lungs).
If the cancer is only in the lymph nodes, at least one node must be at least 1.5cm in size and located outside of the pelvis area.
Your cancer must either be newly diagnosed or have returned after previous treatment.
If the cancer has returned, it must still be hormone sensitive, meaning the cancer cells still grow in response to hormones.
If the cancer has returned, you must have finished all hormone treatments, such as ADT (androgen deprivation therapy, which lowers hormone levels to slow cancer growth) or ARPI (a type of hormone therapy), at least 2 years ago.
You must have received a total of 3 years or less of ADT at the time you are assigned to a study group.
You must have started, or plan to start, long-term androgen deprivation therapy for at least 2 years.
Your WHO Performance Status, which is a scale used by doctors to measure how well you can perform daily activities, must be between 0 and 2. A score of 3 may be acceptable if it is caused by the cancer and is expected to improve with hormone therapy.
You must be willing and able to follow the treatments required for the study.
You must sign an informed consent form, which is a document you sign to show you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

You have small cell carcinoma, which is a specific, aggressive type of cancer that is clearly visible through medical exams or tissue samples.
You have cancer that has spread to your brain or to the leptomeninges, which are the protective layers of tissue that surround your brain and spinal cord.
You have any other active cancers that are growing or required treatment in the last 36 months, excluding certain types of bladder, skin, or cured cancers.
You have any other medical condition that the doctor believes makes it unsafe or unsuitable for you to receive long-term androgen deprivation therapy (a treatment that lowers hormone levels to slow cancer growth) or the study medicines.

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Verified sites

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

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Ludwig Maximilian University Of Munich
Munich, Germany

Trial locations

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Investigated drugs

Pluvicto is a treatment given through a vein that uses a special radioactive substance designed to find and target certain cells in the body to help fight prostate cancer.

Lutetium (177Lu) Vipivotide Tetraxetan

What is already known about the treatment

Lutetium (177Lu) vipivotide tetraxetan - This medication is administered as a liquid through an intravenous infusion directly into a vein. It is a specialized radioactive drug currently used in medical practice to treat advanced prostate cancer that has spread to other parts of the body. The drug works by attaching to specific proteins found on the surface of prostate cancer cells, allowing radiation to be delivered directly to the tumor to destroy the cancer cells while minimizing damage to healthy tissue. It is classified as a radioligand therapy.

Investigated diseases

Metastatic hormone sensitive prostate cancer - This is a type of cancer that begins in the prostate gland and has spread to other parts of the body. The cancer cells are initially responsive to hormone therapy, which works by lowering the levels of hormones that help the cancer grow. As the disease progresses, the cancer cells move beyond the prostate to locations such as the bones or lymph nodes. It is characterized by the presence of cancer in distant organs or tissues while still being influenced by androgen hormones.