Recruiting

Study on Re-treatment with Lutetium (177Lu) Vipivotide Tetraxetan for Men with Metastatic Castration-Resistant Prostate Cancer

Verified siteRegistered drugNo placebo

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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 a treatment for metastatic castration-resistant prostate cancer, a type of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy. The study will use a treatment called [177Lu]Lu-PSMA-617, which is a radiopharmaceutical drug. This means it is a radioactive substance used to target and treat cancer cells. The purpose of the study is to evaluate how effective this treatment is in controlling the cancer's progression over a period of 24 weeks.

Participants in the study will receive the [177Lu]Lu-PSMA-617 treatment through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will monitor the participants' health and the progression of their cancer using imaging techniques like CT scans and bone scans. These scans help doctors see inside the body to check how the cancer is responding to the treatment. The study will also look at the overall survival of participants and any changes in their quality of life during the treatment period.

The trial will include regular follow-up visits to assess the safety and effectiveness of the treatment. Participants will be monitored for any side effects or changes in their condition. The study aims to provide valuable information on whether re-treatment with [177Lu]Lu-PSMA-617 can help manage this type of prostate cancer more effectively, especially for those who have already undergone previous treatments. The results of this study could potentially lead to improved treatment options for patients with advanced prostate cancer.

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
Initial treatment phase
The treatment involves the administration of a radiopharmaceutical drug called [177Lu]Lu-PSMA-617. This drug is given through an intravenous infusion, which means it is delivered directly into the bloodstream.
The dosage and frequency of the drug administration are determined by the study protocol and the healthcare team overseeing the trial.
Step 2
Monitoring and assessment
Regular monitoring is conducted to assess the response to the treatment. This includes imaging tests such as bone scans and CT scans to evaluate the progression of the disease.
Blood tests are performed to measure levels of prostate-specific antigen (PSA) and other relevant markers.
Step 3
Follow-up visits
Scheduled follow-up visits are required to monitor the patient's health and any side effects from the treatment.
During these visits, questionnaires may be used to assess the impact of the treatment on quality of life, including aspects such as pain and overall well-being.
Step 4
End of treatment evaluation
At the end of the treatment period, a comprehensive evaluation is conducted to determine the effectiveness of the therapy.
This evaluation includes a final set of imaging tests and blood work to assess disease progression and response to the treatment.
Step 5
Long-term follow-up
After the treatment phase, long-term follow-up is necessary to monitor the patient's health and any delayed side effects.
The duration and frequency of these follow-up visits are specified by the study protocol.

Who can join the trial?

17 criteria

Must be a male aged 18 years or older.
Must have been treated with at least 4 cycles of [177Lu]Lu-PSMA therapy without signs of the cancer getting worse during this treatment. This includes no worsening seen in scans, symptoms, or PSA levels. PSA is a protein made by the prostate, and its levels can indicate cancer activity.
Must have been treated with at least one ARSI (Androgen Receptor Signaling Inhibitors) like enzalutamide, apalutamide, abiraterone, or darolutamide. These are medications that help manage prostate cancer by blocking male hormones.
Must have received at least one taxane-based chemotherapy such as docetaxel or cabazitaxel. These are drugs used to treat cancer.
Must have signed a consent form agreeing to participate in the study.
Must be willing and able to follow the study rules, including attending follow-up visits and tests.
Must be part of the French social security system.
Must have had at least one course of taxane-based chemotherapy after the first course of [177Lu]Lu-PSMA therapy.
Must agree to use birth control or be unable to father children until 98 days after treatment, unless confirmed to be unable to produce sperm.
Must have adequate organ function, including:
- Healthy bone marrow, which is the tissue inside bones that makes blood cells.
- Healthy liver, which helps process substances in the body.
- Healthy kidneys, which help filter waste from the blood.
- Must have an ECOG performance status of 2 or less. This is a scale that measures how well a person can perform daily activities.
- Must have a confirmed diagnosis of prostate cancer through a tissue sample. Patients with a specific type of prostate cancer called small cell carcinoma may also be included.
- Must have cancer that has spread to other parts of the body, confirmed by scans like bone scans, CT, or MRI.
- Must have confirmed progression of prostate cancer despite ongoing treatment to lower male hormones, with specific criteria for progression.
- Must have PSMA-positive metastatic lesions on a specific type of scan called [68Ga]-PSMA-PET/CT, without any PSMA-negative lesions. PSMA is a protein found on prostate cancer cells, and these scans help identify cancer spread.

Who cannot join the trial?

6 criteria

Patients who have not been previously treated with a first course of [177Lu]Lu-PSMA therapy.
Patients who showed signs of disease progression during the first course of [177Lu]Lu-PSMA therapy.
Patients who have not received at least one taxane-based chemotherapy after the first course of [177Lu]Lu-PSMA. Taxane-based chemotherapy is a type of cancer treatment that uses drugs to stop the growth of cancer cells.
Patients who are female, as the study is only for male subjects.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centre Francois Baclesse
Verified
Caen, France

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Investigated drugs

[177Lu]Lu-PSMA-617 is a type of targeted radiotherapy used in the treatment of prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. 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 surrounding healthy tissue. This study is investigating the effectiveness of re-treating patients with this therapy to see if it can help control the cancer's progression.

What is already known about the treatment

[177Lu]Lu-PSMA-617 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer. It is a radioligand therapy that targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering a radioactive substance directly to the tumor, which helps to destroy cancer cells while minimizing damage to surrounding healthy tissue. The main therapeutic indication is for patients with prostate cancer that has spread and is resistant to hormonal therapy. As a radiopharmaceutical, it combines a targeting molecule with a radioactive component, allowing for precise treatment of cancerous cells.

Investigated diseases

Metastatic Prostate Cancer – This is a type of cancer that begins in the prostate gland and spreads to other parts of the body, such as bones or lymph nodes. It often progresses slowly, but once it spreads beyond the prostate, it can become more aggressive. Symptoms may include difficulty urinating, bone pain, and fatigue. The disease can lead to complications as it affects other organs and systems. It is typically diagnosed through imaging tests and blood tests that measure prostate-specific antigen (PSA) levels. The progression of the disease is monitored through regular medical evaluations and imaging studies.