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Study Comparing Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan for Patients with Advanced Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer. This is a form of prostate cancer that has spread beyond the prostate gland and does not respond to treatments that lower testosterone. The study involves two treatments: Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) vipivotide tetraxetan, also known as Pluvicto. Both treatments are given as a solution for injection and are designed to target and treat cancer cells.

The purpose of the study is to compare how these two treatments work in patients with this type of prostate cancer. Participants will receive both treatments at different times, allowing researchers to observe and compare the effects. The study will look at how well each treatment targets the cancer cells and how it affects other parts of the body, such as the kidneys and salivary glands. This will help determine which treatment might be more effective or safer for patients.

Throughout the study, researchers will monitor the amount of the drug that reaches the tumors and how long it stays there. They will also keep track of any side effects that occur during the treatment. The study aims to provide valuable information that could improve treatment options for patients with metastatic castration-resistant prostate cancer.

1 initial treatment phase

The study involves the administration of two different medications: lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan. Both are given as a solution for injection or infusion.

The medications are administered through an intravenous route, meaning they are injected directly into a vein.

2 imaging and dosimetry

The study is designed to compare the effects of the two medications on the body. This involves imaging techniques to measure how much of the medication is absorbed by the tumors and other organs.

The primary focus is on the ratio of the absorbed dose by the tumors compared to the kidneys. This helps in understanding the therapeutic effects and potential side effects.

3 monitoring and evaluation

Throughout the study, the retention of the medications in the tumors and normal organs is measured. This is done to assess how long the medications stay in the body and their effectiveness.

The study also monitors any side effects that may occur during the treatment period. This includes any new symptoms or changes in health status.

4 completion and follow-up

The study is expected to conclude by November 19, 2025. After the treatment phase, there will be a follow-up period to monitor long-term effects and gather additional data.

Participants are required to agree not to father children or donate sperm during the study and for at least 14 weeks after the last treatment to prevent any potential exposure to the medications.

Who Can Join the Study?

  • The patient must be a male who is at least 60 years old.
  • The patient must have a type of prostate cancer called PSMA-positive prostate cancer that cannot be cured and has spread outside the prostate gland. The patient should be undergoing, have undergone, or be planning to undergo treatment that affects the whole body.
  • The patient must have at least one PSMA-positive lesion (an area of cancer) that can be seen on special scans called PET or CT. This lesion must be at least 1 cm in size for measurement purposes.
  • The patient must have an ECOG performance status of 0-2, which means they are fully active or have some limitations but can still take care of themselves.
  • The patient must have normal functioning of their organs.
  • The patient must be willing to sign a written consent form before any study-related procedures begin.
  • The patient must agree not to father children or donate sperm during the study and for at least 14 weeks after the last treatment. They must also agree to use effective birth control during this time to protect their partners from exposure to the study treatments.

Who Cannot Join the Study?

  • Patients who do not have PSMA-positive non-curative metastatic castration-resistant prostate cancer cannot participate. This means the cancer must be resistant to treatments that lower testosterone and has spread to other parts of the body.
  • Only male patients are eligible for this study. Female patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Stichting Radboud University Medical Center Nijmegen The Netherlands
Iernejly Rdolbmny Dl Cpjmut Dw Mgmwglivhuz Montpellier France
Cuwtnp Llgo Bbduwv Lyon France
Ulqcsazkihaetmdldejwb Aoplkonx Augsburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.02.2025
Germany Germany
Not recruiting
28.02.2025
Spain Spain
Not recruiting
28.02.2025
The Netherlands The Netherlands
Not recruiting
28.02.2025

Trial locations

Investigated drugs:

Lutetium (177Lu) rhPSMA-10.1 is a type of targeted therapy used in the treatment of prostate cancer that has spread to other parts of the body and cannot be cured with standard treatments. This therapy involves a radioactive substance, lutetium-177, which is attached to a molecule that specifically targets prostate cancer cells. The goal is to deliver radiation directly to the cancer cells, minimizing damage to healthy tissues.

Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) is another targeted therapy for metastatic prostate cancer. Similar to lutetium (177Lu) rhPSMA-10.1, it uses the radioactive element lutetium-177 to target and destroy cancer cells. This therapy is designed to improve outcomes for patients by focusing the radiation on cancer cells while sparing normal cells, potentially reducing side effects compared to traditional radiation therapy.

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 spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Metastatic castration-resistant prostate cancer is a form where the cancer continues to grow despite treatments that lower testosterone. This type of cancer can lead to symptoms like difficulty urinating, pelvic pain, and bone pain. The progression and symptoms can vary widely among individuals.

Trial ID:
2024-515264-31-00
Protocol code:
BET-PSMA-001
NCT ID:
NCT06516510
Trial Phase:
Human Pharmacology (Phase I) – Other

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