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Study of Lutetium (177Lu) Vipivotide Tetraxetan and Ipilimumab for Men with Very High-Risk 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 treatments for very high-risk prostate cancer. The study involves two treatments: 177-Lutetium-PSMA-617, a type of radioligand therapy, and Ipilimumab, an immunotherapy drug. The purpose of the study is to explore the feasibility and effectiveness of these treatments when used before surgery in men with this type of prostate cancer.

Participants in the study will receive either the radioligand therapy alone or in combination with the immunotherapy. The study will monitor the ability to perform surgery on the prostate after the treatment, as well as the response of the cancer to the treatment. The study will also track any side effects experienced by participants and how long they remain free from cancer progression after surgery.

The trial is expected to run until 2027, with recruitment starting in 2024. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments. This study aims to provide valuable insights into new treatment options for men with very high-risk 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 begins with the administration of Pluvicto, which contains the active substance lutetium (177lu) vipivotide tetraxetan. This is provided as a solution for injection or infusion.
The dosage and frequency of administration will be determined by the medical team based on individual patient needs and the study protocol.
Step 2
Combination therapy phase
In this phase, Ipilimumab is introduced. It is a concentrate for solution for infusion.
The combination of Pluvicto and Ipilimumab aims to enhance the treatment effect. The specific dosage and schedule will be provided by the healthcare provider.
Step 3
Monitoring and assessment phase
Throughout the treatment, regular monitoring will occur to assess the body's response to the therapy. This includes blood tests and imaging studies.
The primary goal is to evaluate the feasibility of performing a prostatectomy on day 85, with a possible delay of up to 3 weeks if necessary.
Step 4
Surgical intervention phase
If the treatment is deemed feasible, a radical prostatectomy with pelvic lymph node dissection will be performed.
The surgery aims to remove the prostate and any affected lymph nodes to manage the cancer effectively.
Step 5
Post-surgery follow-up phase
After surgery, follow-up visits will be scheduled to monitor recovery and check for any signs of cancer recurrence.
The follow-up period includes monitoring for adverse events and assessing PSA progression-free survival for up to one year after the prostatectomy.

Who can join the trial?

18 criteria

Must be at least 18 years old.
If sexually active, must use a condom to prevent fathering a child and to prevent passing the study treatment to a partner through seminal fluid for at least 14 weeks after the last dose of the study medication.
Must have tumor tissue from both a prostate biopsy and a radical prostatectomy available for review by a specialist.
Must sign an informed consent form, which means you understand the study's purpose and procedures and agree to participate.
Must have a confirmed diagnosis of prostate cancer with specific criteria: a very high-risk score called a **Gleason Score** of 4+4 or higher, a clinical stage called **cT3**, and either a positive clinical nodal status or a **Serum-PSA** level greater than 20 ng/ml.
Must not have cancer that has spread to other parts of the body, as shown by imaging tests.
Must not have received any previous treatment for prostate cancer.
Must have a performance status of 0-1 on the **ECOG** scale, which measures how well you can carry out daily activities.
Must be a candidate for a surgery called radical prostatectomy with pelvic lymph node dissection.
Must have a positive result on a specific imaging test called a **PSMA PET scan**, with a certain score.
Must meet specific laboratory criteria within 14 days before starting the study, including:
- **Bone Marrow**: White blood cells, neutrophils, platelets, and hemoglobin levels must be within certain ranges.
- **Liver Function**: AST/ALT and total bilirubin levels must be within certain limits.
- **Kidney Function**: Serum creatinine must be within a specific range.
- **Thyroid Function**: TSH levels must be normal, or further tests are needed if not.
- **Albumin**: Must be above a certain level.
- **Electrolytes**: Potassium and sodium levels must be within specific ranges.
- **Pancreatic Enzymes**: Amylase and lipase levels must be within certain limits.
- **Blood Sugar**: Must be below a specific level.

Who cannot join the trial?

5 criteria

Patients who do not have very high-risk prostate cancer as defined by specific medical criteria.
Patients who are not candidates for a surgery called radical prostatectomy, which involves removing the prostate gland and some surrounding tissue.
Patients who are not eligible for pelvic lymph node dissection, a procedure to remove lymph nodes in the pelvic area.
Patients who are female, as the study is only for male participants.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

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Verified sites

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Universitaetsklinikum Essen AöR
Verified
Essen, Germany

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Investigated drugs

177Lu-PSMA-617
is a type of targeted radiotherapy used in this trial. It is designed to deliver radiation directly to prostate cancer cells by binding to a specific protein found on the surface of these cells. This helps to destroy the cancer cells while minimizing damage to surrounding healthy tissue.
Ipilimumab
is an immunotherapy medication used in this trial. It works by stimulating the body's immune system to attack cancer cells. Ipilimumab blocks a specific protein that usually helps keep immune responses in check, allowing the immune system to better recognize and destroy cancer cells.

What is already known about the treatment

177-Lutetium-PSMA-617
This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating very high-risk prostate cancer. It is a radiolabeled molecule that targets the prostate-specific membrane antigen (PSMA) on prostate cancer cells, delivering targeted radiation to destroy these cells. It is classified as a radiopharmaceutical and is being explored for its effectiveness in reducing tumor size before surgery.
Ipilimumab
This medication is given as an intravenous infusion and is approved for use in certain types of cancer, with ongoing research in prostate cancer. It works by activating the immune system to attack cancer cells, specifically by blocking CTLA-4, a protein that downregulates immune responses. Ipilimumab is classified as an immune checkpoint inhibitor and is being investigated for its potential to enhance the effects of other treatments in high-risk prostate cancer.

Investigated diseases

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 lead to difficulties in urination, blood in urine, or pelvic discomfort. The disease can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The risk of developing prostate cancer increases with age, and it is more common in men over 50. Factors such as genetics and lifestyle may also influence its development.