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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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.
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.
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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Lucus Augusti	Lugo	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Hjrbxhgy Ukckxmzncksep Mvvlmih Du Vowktpgsct	Santander	Spain
Ifjnmikl Ccnpeb Dswxidzzxcdtvzgwk	L'hospitalet De Llobregat	Spain
Fpzgtugih Pvdm Ll Iymifhrcrrxup Bdqipmiio Dzq Hoytchfe Uoekcpkjhthip La Pik	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.12.2022

Trial locations

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.

Investigated diseases:

Neuroendocrine carcinoma of prostate

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.

Trial ID:

2022-501139-17-01

Protocol code:

PEAPOD-FOS04/2022

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?