Study of [225Ac]Ac-PSMA-R2 for Men with Advanced Prostate Cancer Previously Treated or Not with 177Lu-PSMA Therapy

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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 (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is investigating a new treatment called 225Ac-PSMA-R2, which is being tested in men who have already received extensive treatment for their cancer. Some participants may have previously received a specific type of therapy known as 177Lu-labelled PSMA-targeted radioligand therapy, while others have not.

The purpose of the study is to understand the safety and tolerability of the new treatment, as well as its ability to fight the cancer. Participants will be divided into two groups: those who have had the 177Lu therapy before and those who have not. The study will involve taking the new treatment and monitoring its effects over time. This includes checking for any side effects and seeing how well the cancer responds to the treatment.

Throughout the study, participants will receive the treatment and be closely monitored by healthcare professionals. The treatment will be given through an injection, and participants will have regular check-ups to assess their health and the progress of their cancer. The study aims to find the best dose of the new treatment and to see how effective it is in treating this challenging form of prostate cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, current health status, and previous treatments.

A series of tests and scans, such as CT, MRI, or bone scans, are performed to establish a baseline for the study.

2 treatment group assignment

Participants are assigned to one of two groups based on previous treatments. Group 1 includes those who have received prior 177Lu-labelled PSMA-targeted therapy, while Group 2 includes those who have not.

The assignment determines the specific treatment regimen and monitoring schedule.

3 treatment administration

The treatment involves the administration of 225Ac-PSMA-R2, a radioligand therapy. The method of administration is intravenous, meaning it is delivered directly into the bloodstream.

The dosage and frequency are determined based on the group assignment and individual health factors. The treatment cycle is repeated as per the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests, imaging scans, and health evaluations.

Participants are observed for any side effects or adverse reactions. Adjustments to the treatment may be made based on these observations.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is performed to determine the overall response to the therapy.

This includes assessing changes in tumor size, progression of the disease, and any improvements in symptoms.

6 long-term follow-up

Participants may be asked to attend follow-up visits to monitor long-term effects and overall health status.

These visits help in understanding the lasting impact of the treatment and contribute to future research.

Who Can Join the Study?

Ability to understand and sign an approved Informed Consent Form, and to understand and comply with all study requirements.
Must have had a prior surgery to remove the testicles (orchiectomy) or be on ongoing hormone therapy (ADT).
Must have either received or not received previous treatment with a specific type of therapy called 177Lu-labelled PSMA-targeted RLT depending on the group they are in.
Must have adequate organ function, which includes:
- Bone marrow reserve: Sufficient levels of white blood cells, neutrophils, and platelets.
- Liver function: Acceptable levels of bilirubin, ALT, and AST enzymes.
- Kidney function: Creatinine clearance of at least 60 mL/min. Participants with urinary blockages are not eligible.
Participants with HIV who are healthy and have a low risk of AIDS-related outcomes are eligible.
If participants have partners who can become pregnant, they must use a reliable method of birth control during the study and for 6 months after the last study drug is given.
Must be an adult aged 18 years or older.
Must have a performance status that allows them to carry out daily activities with minimal or moderate restrictions.
Must have confirmed prostate cancer through medical tests.
Must have at least one metastatic lesion visible on imaging tests like CT, MRI, or bone scans.
Must show evidence of PSMA-positive disease through a specific PET/CT scan.
Must have recovered or stabilized from any significant side effects of previous prostate cancer treatments, except for certain conditions like mild nerve damage or hair loss.
Must have documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on specific criteria like rising PSA levels, tumor growth, or new bone lesions.
Must have a low level of testosterone in the blood.

Who Cannot Join the Study?

Patients who do not have PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC) cannot participate. This means the cancer must show a specific marker called PSMA and must have spread to other parts of the body and not respond to treatments that lower testosterone.
Only male patients can participate. Female patients are not eligible.
Patients who are considered part of a vulnerable population are not eligible. This generally refers to groups who may have difficulty giving informed consent or are at higher risk of being exploited.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France
Centre Jean Perrin	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Cpugwa Lzox Bidrfg	Lyon	France
Crxc Dy Nrzgo	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	07.11.2023

Trial locations

Investigated drugs:

225Ac-PSMA-R2 is a type of treatment that uses a radioactive substance to target and attack prostate cancer cells. This therapy is specifically designed for men with a type of prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatments. The treatment works by attaching to a protein found on the surface of prostate cancer cells, allowing the radioactive substance to directly target and kill these cancer cells while minimizing damage to healthy cells. This therapy is being tested to see how safe it is for patients and how well it can reduce or eliminate cancer in those who have already received other similar treatments, as well as those who have not.

PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC) – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It is characterized by the spread of cancer cells to other parts of the body, such as bones and lymph nodes, which is referred to as metastasis. The cancer cells express a protein called Prostate-Specific Membrane Antigen (PSMA), which can be targeted by specific therapies. As the disease progresses, patients may experience symptoms related to the spread of cancer, such as bone pain or urinary issues. The progression of mCRPC can vary, with some patients experiencing a slow progression while others may have a more rapid advancement of the disease. The focus of ongoing research is to better understand the disease and develop targeted therapies to manage its progression.

Trial ID:

2023-507672-52-00

Protocol code:

CAAA802A12101

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of [225Ac]Ac-PSMA-R2 for Men with Advanced Prostate Cancer Previously Treated or Not with 177Lu-PSMA Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?