Study on the Safety and Effects of Lutetium (177Lu) Vipivotide Tetraxetan in Patients with Advanced Prostate Cancer and Different Levels of Kidney Function

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. The study will use a treatment called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This treatment is a special type of medicine that is injected into the bloodstream and is designed to target and treat cancer cells.

The purpose of the study is to understand how this treatment behaves in the body, especially in patients with different levels of kidney function, ranging from normal to severely impaired. Participants will receive the treatment through an injection, and the study will monitor how the medicine spreads in the body, how safe it is, and how well it is tolerated by patients. The study will also look at how the treatment affects the kidneys and other organs over time.

Throughout the study, participants will undergo various tests and scans to track the treatment’s effects and any side effects. These tests will help researchers gather important information about the treatment’s safety and effectiveness. The study aims to provide valuable insights into how lutetium (177Lu) vipivotide tetraxetan can be used to treat this challenging form of prostate cancer, especially in patients with different kidney health conditions.

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 a performance status score between 0 and 2, a positive PET/CT scan, and specific testosterone levels. Progressive prostate cancer must be documented, and kidney function is assessed using eGFR values.

2 baseline measurements

Baseline measurements are taken to establish a starting point for the study. These include blood tests, imaging scans, and assessments of kidney function.

The primary focus is on measuring the absorbed radiation dose in the kidneys and other organs, as well as the concentration of the study drug in the blood.

3 medication administration

The study involves the administration of two medications: gozetotide and lutetium (177Lu) vipivotide tetraxetan. Both are given as solutions for injection or infusion through a vein.

The dosage and frequency of administration are determined by the study protocol and are based on individual health assessments.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any side effects and changes in laboratory values, vital signs, and heart function.

Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to make any necessary adjustments to the dosage or treatment plan.

5 end of study evaluation

At the end of the study, a comprehensive evaluation is performed to assess the overall impact of the treatment on prostate cancer progression and kidney function.

Final measurements are compared to baseline data to determine any changes in health status and to evaluate the success of the treatment.

Who Can Join the Study?

Must be a male patient.
Have a type of prostate cancer called Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a way to measure how well you can perform daily activities.
Have a positive result on a special scan called 68Ga-PSMA-11 PET/CT, which helps to see cancer in the body.
Have a castrate level of testosterone in the blood, which means very low testosterone levels (less than 50 ng/dL or 1.7 nmol/L).
Show signs of cancer getting worse, which can be seen by:
- Increasing levels of a protein called Prostate-Specific Antigen (PSA) in the blood.
- Growth of cancer in soft tissues, which means the size of cancer spots is getting bigger.
- New or worsening cancer spots in the bones.
Have stable kidney health, meaning no big changes in kidney function in the last 4 weeks.
Have specific levels of kidney function measured by a test called eGFR:
- Normal kidney function: eGFR of 90 mL/min or higher.
- Moderate kidney issues: eGFR between 30 to 59 mL/min.
- Severe kidney issues: eGFR between 15 to 29 mL/min.

Who Cannot Join the Study?

Patients who do not have Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
Patients who are female, as the study is only for male participants.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospices Civils De Lyon	Lyon	France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Cmkc Di Ngloh	Vandoeuvre Les Nancy	France
Axwwxoqljh Ptgnallh Hvisonfk Dy Pkcol	Paris	France
Ugfwocptanjqcpcaqcqlz Eicwu Agy	Essen	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	29.12.2023
Germany	Not recruiting	29.12.2023
Italy	Not recruiting	29.12.2023
Spain	Not recruiting	29.12.2023

Trial locations

Investigated drugs:

AAA617 is a medication being studied for its effects on patients with prostate cancer that has spread and is resistant to standard hormone therapy. This medication is designed to target and bind to specific proteins found on prostate cancer cells, allowing it to deliver radiation directly to the cancer cells. The study aims to understand how the medication is distributed in the body, how safe it is, and how well patients tolerate it, especially in those with different levels of kidney function.

Investigated diseases:

Hormone-refractory prostate cancer

Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This is a type of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. It is characterized by the presence of prostate-specific membrane antigen (PSMA) on cancer cells, which can be targeted for imaging and therapy. The disease often spreads to bones and other organs, making it more challenging to manage. Patients with this condition may experience symptoms such as bone pain, urinary issues, and fatigue. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. The focus of research often includes understanding how the disease progresses in individuals with different levels of kidney function.

Trial ID:

2023-503925-20-00

Protocol code:

CAAA617A12202

NCT ID:

NCT06004661

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Lutetium (177Lu) Vipivotide Tetraxetan in Patients with Advanced Prostate Cancer and Different Levels of Kidney Function

What is this study about?

Who Can Join the Study?

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