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Study of Pembrolizumab, Carboplatin, and Cabazitaxel for Patients with Aggressive Metastatic Castration-Resistant Prostate Cancer

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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 type of prostate cancer known as . This is a form of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone. The study will test a combination of three treatments: , , and . Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer. Carboplatin and Cabazitaxel are chemotherapy drugs that work by stopping cancer cells from growing and dividing.

The purpose of the study is to evaluate the effectiveness and safety of this combination of treatments. Participants will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will monitor how the cancer responds to the treatment over a period of time, specifically looking at how long the cancer can be controlled without getting worse. This is known as progression-free survival. The study will also track any side effects that participants may experience during the treatment.

Throughout the study, participants will undergo regular imaging tests, such as or scans, to check the status of the cancer. Blood tests and other assessments will also be conducted to ensure the safety and well-being of the participants. The study aims to provide valuable information on whether this combination of treatments can be an effective option for patients with this aggressive form of 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
Beginning of the trial
Upon joining the trial, you will receive detailed information about the study, including its purpose, procedures, and potential risks and benefits. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.
Step 2
Initial assessments
Before starting the treatment, initial assessments will be conducted. These may include blood tests, imaging studies such as bone scans, CT or MRI scans, and a review of your medical history to confirm eligibility.
A sample of your tumor tissue will be collected if not already available. This helps in understanding the specific characteristics of your cancer.
Step 3
Treatment phase
You will receive a combination of three medications: pembrolizumab, carboplatin, and cabazitaxel. These medications are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.
The specific dosage and frequency of these medications will be determined by the study protocol and your healthcare team. The treatment phase will continue for a specified duration, during which your response to the treatment will be closely monitored.
Step 4
Regular monitoring
Throughout the trial, regular monitoring will be conducted to assess your health and the effectiveness of the treatment. This includes routine blood tests, imaging studies, and evaluations of any side effects you may experience.
Your healthcare team will provide guidance on managing any side effects and will adjust your treatment plan as necessary to ensure your safety and well-being.
Step 5
Follow-up assessments
After completing the treatment phase, follow-up assessments will be conducted to evaluate the long-term effects of the treatment. This may include additional imaging studies and blood tests.
The follow-up period is important for understanding the overall impact of the treatment on your cancer and general health.
Step 6
End of trial
At the end of the trial, you will have a final consultation with your healthcare team to discuss the results of your participation and any further steps in your treatment plan.
You will be provided with information on how to continue monitoring your health and any additional care you may need.

Who can join the trial?

18 criteria

Male participants who are at least 18 years old on the day of signing the consent form.
Have adequate organ function as defined by the study's requirements. Tests must be done within 10 days before starting the study treatment.
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For participants with a known history of Hepatitis B or Hepatitis C:
- Hepatitis B positive participants are eligible if they have been on antiviral therapy for at least 4 weeks and have an undetectable viral load before starting the study.
- Participants with a history of Hepatitis C are eligible if their viral load is undetectable at screening and they completed antiviral therapy at least 4 weeks before starting the study.
- Have a confirmed diagnosis of prostate cancer, specifically adenocarcinoma or neuroendocrine carcinoma.
- Have metastatic disease, which means the cancer has spread to other parts of the body, as shown by imaging tests like bone scans, CT scans, or MRI scans.
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  Meet at least one of the following criteria for Aggressive Variant Prostate Cancer (AVPC):
  - Proven small cell (neuroendocrine) prostate cancer.
  - Only visceral metastases, meaning the cancer has spread to internal organs.
  - Predominantly lytic bone metastases, which are areas where the cancer has caused bone loss.
  - Large lymph nodes (5 cm or larger) or high-grade pelvic/prostatic masses.
  - Low PSA (10 ng/ml or less) at initial presentation with extensive disease (20 or more metastases).
  - High levels of LDH or CEA in the blood, which are markers that can indicate cancer activity.
  - Quick progression to castration-resistance (6 months or less).
  - Agree to use contraception during the treatment period and for a specified time after the last dose, and agree not to donate sperm during this time.
  - Provide written informed consent to participate in the trial.
  - Have measurable disease based on specific criteria (RECIST 1.1). If the cancer was previously treated with radiation, it must show progression to be considered measurable.
  - Provide a tumor tissue sample from the past year or a new biopsy of a tumor that has not been treated with radiation. Tissue blocks are preferred over slides, and new biopsies are preferred over older samples.
  - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which is a scale used to assess how the disease affects daily living abilities. This assessment must be done within 7 days before the first dose of study treatment.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who have not been diagnosed with metastatic castration-resistant prostate cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
Patients who are female cannot participate, as the study is only for male patients.
Patients who are considered part of a vulnerable population, such as those unable to give informed consent, cannot participate.

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Verified sites

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

Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Clinico San Carlos
Madrid, Spain

Trial locations

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Investigated drugs

Pembrolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is used to see if it can help control aggressive prostate cancer when combined with other treatments.
Carboplatin
is a chemotherapy drug that is used to kill cancer cells. It works by damaging the DNA inside the cancer cells, which stops them from growing and dividing. In this trial, carboplatin is used alongside other medications to see if it can improve treatment outcomes for prostate cancer.
Cabazitaxel
is another chemotherapy medication that targets cancer cells. It works by interfering with the structures inside the cells that are needed for them to divide and grow. In this study, cabazitaxel is combined with other treatments to evaluate its effectiveness in treating aggressive prostate cancer.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating aggressive variant metastatic castration-resistant prostate cancer. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.
Carboplatin
Carboplatin is administered intravenously, allowing it to enter the bloodstream directly. It is a well-established chemotherapy drug used in various cancer treatments, including in clinical trials for aggressive variant metastatic castration-resistant prostate cancer. Its primary therapeutic role is to damage the DNA of cancer cells, preventing them from dividing and growing. At the molecular level, carboplatin forms cross-links with DNA, disrupting the DNA structure and function. It is classified as a platinum-based chemotherapy agent.
Cabazitaxel
Cabazitaxel is given as an intravenous infusion, which means it is delivered directly into the bloodstream. It is currently used in clinical settings and trials for treating advanced prostate cancer, particularly when other treatments have failed. The main therapeutic indication for cabazitaxel is to inhibit cancer cell growth by interfering with cell division. At the molecular level, it binds to tubulin, a protein that is essential for cell division, thereby preventing cancer cells from multiplying. Cabazitaxel is classified as a taxane chemotherapy drug.

Investigated diseases

Aggressive Variant Metastatic Castration-Resistant Prostate Cancer – This form of prostate cancer is characterized by its resistance to hormonal therapy, which is typically used to lower testosterone levels. It progresses despite the reduction of male hormones that usually fuel prostate cancer growth. The disease is termed "aggressive variant" due to its rapid progression and tendency to spread to other parts of the body, such as bones and lymph nodes. It often presents with a high tumor burden and may exhibit features similar to small cell carcinoma. As the cancer advances, patients may experience symptoms related to metastasis, including bone pain and urinary issues. The disease's progression is monitored through imaging and biomarkers, which help assess the extent of cancer spread and activity.