Not recruiting

Study Comparing 177Lu-PSMA-617 with Standard Treatment for Men with Metastatic Hormone-Sensitive Prostate Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 type of prostate cancer known as metastatic hormone-sensitive prostate cancer (mHSPC). The trial is investigating the effectiveness of a treatment called 177Lu-PSMA-617, which is used in combination with the standard care for this condition. The standard care may include various medications such as relugolix, goserelin acetate, triptorelin acetate, degarelix, bicalutamide, apalutamide, enzalutamide, darolutamide, abiraterone, flutamide, nilutamide, buserelin, histrelin, and leuprorelin. The purpose of the study is to evaluate how well the combination of 177Lu-PSMA-617 and standard care works compared to standard care alone in treating mHSPC.

Participants in the study will receive either the combination treatment or the standard care alone. The study will monitor the progress of the disease using imaging techniques to see if the cancer is spreading or staying the same. The trial will also look at overall survival, which means how long patients live after starting the treatment, and other health outcomes. The study will last for a period of time, and participants will be regularly checked to see how they are responding to the treatment.

This trial is important for understanding if adding 177Lu-PSMA-617 to the standard care can improve outcomes for patients with mHSPC. The study will help determine if this new combination treatment can help control the cancer more effectively than the standard care alone. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This ensures understanding of the study's purpose and procedures.
Eligibility is confirmed based on specific criteria, including age, health status, and medical history related to prostate cancer.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving 177Lu-PSMA-617 with standard care, and the other receiving standard care alone.
This process ensures unbiased comparison between the two treatment approaches.
Step 3
Treatment phase
For those receiving 177Lu-PSMA-617, the medication is administered as a solution for injection or infusion.
Standard care may include medications such as relugolix, goserelin acetate, triptorelin acetate, degarelix, and others, depending on individual treatment plans.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the effectiveness of the treatment. This includes imaging tests to track disease progression.
Blood tests and other evaluations are performed to monitor health status and any side effects.
Step 5
Follow-up
Participants continue to be monitored for overall survival and progression-free survival.
Additional assessments may include quality of life evaluations and tracking of any adverse events.
Step 6
Completion of the study
The study is expected to conclude by February 2026.
Final results will be analyzed to determine the effectiveness and safety of the treatment options.

Who can join the trial?

17 criteria

You must sign a form to show you understand and agree to participate in the study.
If you have HIV but are healthy and have a low risk of developing AIDS-related issues, you can join the trial.
You should be either new to treatment or have had minimal treatment for prostate cancer. This means:
- Up to 45 days of certain hormone treatments or surgery to remove the testicles is allowed before signing the consent form. If you took a specific type of medication called first-generation antiandrogen, it must be stopped before starting the study treatment or after 45 days, whichever comes first.
- If you had hormone treatments in the past for early-stage prostate cancer, they must have been stopped more than 12 months before signing the consent form, and the treatment should not have lasted more than 24 months. Also, the cancer should not have worsened within 12 months after stopping the treatment.
- Up to 45 days of certain other medications for prostate cancer is allowed before signing the consent form, but not for earlier stages of prostate cancer.
- You must be an adult, at least 18 years old.
- Your ability to perform daily activities should be rated between 0 to 2 on a specific scale used by doctors, known as the **ECOG performance status**.
- You should have a life expectancy of more than 9 months, as determined by the study doctor.
- You must have prostate cancer that has spread to other parts of the body, confirmed by a biopsy, which is a test that examines tissue samples.
- Your cancer must show **PSMA-positive** results on a special scan called a **68Ga-PSMA-11 PET/CT scan**, and you must be eligible as determined by the study's central reader.
- You must have at least one area where the cancer has spread, either to the bones or other tissues, documented within 28 days before starting the study. This can be shown by:
  - Cancer in the bones visible on a specific type of bone scan.
  - Cancer in the lymph nodes, which are small glands that help fight infection. If lymph nodes are the only area affected, at least one must be a certain size and located outside the pelvis.
  - Cancer in other organs, known as visceral metastases. If you had this type of spread before starting hormone treatment and it disappeared, it will still be counted as having spread for study purposes.
  - Your organs must be working well, which means:
    
    Your bone marrow, which produces blood cells, should have enough reserves. This is measured by certain blood counts.
    Your liver function should be within normal limits, with some allowances for specific conditions like **Gilbert's Syndrome**.
    Your kidneys should be functioning well, measured by a test called **eGFR**.
    Your blood protein level, known as **albumin**, should be at least 2.5 g/dL.

Who cannot join the trial?

3 criteria

Patients who do not have **PSMA-positive metastatic hormone-sensitive prostate cancer** cannot participate. This means the cancer must have spread to other parts of the body and still responds to hormone treatment.
Only **male** patients are eligible for this study.
Patients who are 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 harm.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

177Lu-PSMA-617
is a type of targeted therapy used in this clinical trial. It is designed to deliver radiation directly to prostate cancer cells. This medication works by attaching to a specific protein found on the surface of prostate cancer cells, allowing the radiation to target and kill these cells more effectively while minimizing damage to healthy cells.
Standard of Care
refers to the regular treatment that patients with metastatic hormone-sensitive prostate cancer typically receive. This can include a combination of hormone therapy, chemotherapy, or other treatments that are commonly used to manage prostate cancer. The exact components of the Standard of Care can vary depending on the patient's specific condition and the healthcare provider's recommendations.

What is already known about the treatment

177Lu-PSMA-617 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating PSMA-positive metastatic hormone-sensitive prostate cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. The main therapeutic indication is for prostate cancer that has spread and is sensitive to hormone therapy. At the molecular level, 177Lu-PSMA-617 targets the prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to the tumor, which helps to destroy cancer cells. It is classified as a radiopharmaceutical, a type of drug that combines a radioactive component with a molecule that targets specific cells.

Investigated diseases

PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) – This is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The cancer cells express a protein called PSMA, which can be targeted for treatment. As the disease progresses, it may become resistant to hormone therapy, leading to further spread and growth of cancer cells. The progression is often monitored through imaging and PSA levels, which can indicate changes in the cancer's activity. Over time, the disease may transition to a more advanced stage known as castration-resistant prostate cancer.