Not recruiting

Study of Pembrolizumab and 68GA-PSMA HBED-CC in Patients with 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 high-risk prostate cancer, a condition where cancer cells form in the tissues of the prostate and have a higher chance of spreading to other parts of the body. The study will use a treatment called pembrolizumab, which is a type of medication that helps the immune system fight cancer. Pembrolizumab is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of this study is to see if using pembrolizumab before surgery can reduce the chance of cancer spreading to the lymph nodes in patients with high-risk prostate cancer. The study will involve patients receiving pembrolizumab before undergoing a surgical procedure called a radical prostatectomy, which is the removal of the prostate gland. The study will also use a substance called [68GA]PSMA-HBED-CC, which is used in imaging to help doctors see where the cancer is located in the body.

Participants in the study will receive pembrolizumab for a certain period before their surgery. The study aims to determine if this approach can lower the rate of cancer spreading to the lymph nodes compared to what is currently reported in medical literature. The study will be conducted over a period of time, and the results will help understand the effectiveness of pembrolizumab in treating high-risk prostate cancer.

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, eligibility is confirmed based on specific criteria, including age, diagnosis of prostate cancer, and risk of lymph node invasion.
Written informed consent is required to participate in the study.
Step 2
Treatment with pembrolizumab
The treatment involves the administration of pembrolizumab, a medication given through an intravenous infusion.
The specific dosage and frequency of administration are determined by the study protocol and medical team.
Step 3
Monitoring and assessments
Regular monitoring and assessments are conducted to evaluate the response to the treatment.
These assessments may include imaging studies and laboratory tests to track the progress of the treatment.
Step 4
Surgery preparation
Preparation for radical prostatectomy and extended pelvic lymph node dissection (ePLND) is undertaken.
The timing of the surgery is coordinated based on the treatment response and medical evaluations.
Step 5
Surgery
The surgical procedure involves the removal of the prostate gland and potentially affected lymph nodes.
The goal is to reduce the risk of cancer recurrence by addressing areas at high risk of invasion.
Step 6
Post-surgery follow-up
Follow-up care is provided to monitor recovery and assess the outcomes of the surgery.
Further evaluations may be conducted to determine the effectiveness of the treatment in reducing lymph node invasion.

Who can join the trial?

6 criteria

Male participants who are at least 18 years old on the day they sign the informed consent form, with a confirmed diagnosis of prostate cancer.
Prostate cancer detected at a prostate biopsy with a risk of cancer spreading to the lymph nodes higher than 5%, according to a specific calculation tool called the Briganti nomogram.
The participant should be in good health and planned for a surgery called RP (radical prostatectomy) and ePLND (extended pelvic lymph node dissection).
The participant, or their legally acceptable representative if needed, must provide written informed consent to participate in the trial.
The participant must not have started any new treatments within the 4 weeks before the study begins.
The participant must be willing to use contraception during the study treatment.

Who cannot join the trial?

4 criteria

Patients who are not male cannot participate.
Patients who do not have high-risk prostate cancer cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population, which means groups that may need special protection, cannot participate.

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Verified sites

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Ospedale San Raffaele S.r.l.
Verified
Milan, Italy

Trial locations

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Investigated drugs

Pembrolizumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body's immune system fight cancer cells. In this study, pembrolizumab is given to patients with high-risk prostate cancer before they undergo surgery to remove the prostate. The goal is to see if this treatment can reduce the chance of cancer spreading to the lymph nodes.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered intravenously, typically through an infusion into a vein. It is currently well-established in medical literature as an immunotherapy drug used in various cancer treatments. The main therapeutic indication for pembrolizumab in this context is high-risk prostate cancer, particularly as a neoadjuvant therapy before surgery. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. It is classified as a monoclonal antibody and is part of the broader class of immune checkpoint inhibitors.

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 cause urinary problems, pelvic discomfort, or bone pain. High-risk prostate cancer refers to cases with a greater likelihood of spreading beyond the prostate. This type of cancer may invade nearby tissues or lymph nodes. Monitoring and understanding its progression are crucial for managing the disease effectively.