Study of Ebastine and Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer in Patients with Advanced Disease

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is testing a combination of two treatments: Ebastine, which is usually used to treat allergies, and Docetaxel, a chemotherapy drug commonly used to treat various cancers.

The purpose of the study is to explore how effective this combination is in treating mCRPC. Participants in the study will receive either the combination of Ebastine and Docetaxel or a placebo. The study will monitor changes in certain markers in the blood and urine, as well as the response of prostate-specific antigen (PSA), which is a protein produced by prostate cells. A decrease in PSA levels can indicate that the treatment is working. The study will also look at how long patients can go without the cancer getting worse and any side effects from the treatment.

The study will take place over a period of time, with regular check-ups and assessments to track the progress of the treatment. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather important information about the effectiveness of the treatment. The study aims to provide new insights into potential treatment options for those living with metastatic castration-resistant prostate cancer.

1 joining the trial

Upon joining the trial, you will be asked to provide your signed informed consent. This is a document that confirms you understand the trial and agree to participate.

You will need to meet certain criteria, such as having a confirmed diagnosis of prostate cancer that has spread and is resistant to standard hormone therapy. Your doctor will check if you meet these criteria.

2 initial assessments

Before starting the treatment, you will undergo several assessments. These may include blood tests, imaging scans like CT or MRI, and other evaluations to check your overall health and the status of your cancer.

These assessments help establish a baseline to compare with future results during the trial.

3 treatment phase

You will receive a combination of two medications: ebastine and docetaxel. Ebastine is taken orally as a 20 mg film-coated tablet. The frequency and duration of taking ebastine will be explained by your healthcare provider.

Docetaxel is administered through an intravenous infusion, which means it is given directly into your vein. The schedule for receiving docetaxel will be determined by your healthcare team.

4 regular monitoring

Throughout the trial, you will have regular appointments to monitor your health and the effects of the treatment. This includes blood tests to measure specific markers and imaging tests to track the cancer’s response.

Your healthcare team will also check for any side effects from the medications and adjust your treatment if necessary.

5 end of treatment

At the end of the treatment phase, you will have a final set of assessments similar to the initial ones. These will help determine the overall impact of the treatment on your cancer.

Your healthcare team will discuss the results with you and plan any further steps needed for your care.

Who Can Join the Study?

Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate. This means the type of prostate cancer must be confirmed by examining tissue under a microscope. Certain types of cancer cells are not allowed.
Must be surgically or medically castrated, meaning the body has very low levels of the male hormone testosterone (≤ 50 ng/dL or 1.7 nmol/L). If you are taking medication to lower testosterone, you must continue this treatment during the study.
Show evidence of disease progression after previous treatment for metastatic castration-resistant prostate cancer (mCRPC). This can be shown by:
- A rise in PSA (Prostate-Specific Antigen) levels, with at least two rising measurements taken at least one week apart, and the most recent level being ≥ 2 ng/mL.
- New or growing soft tissue masses seen on CT or MRI scans.
- At least two new metastatic lesions on a bone scan.
Provide signed informed consent before starting any study-specific procedures or treatments. This means you agree to participate after being informed about the study.
Be at least 18 years old.
Have a life expectancy of at least 3 months.
Have a performance status of 0 – 1, which means you are fully active or have some symptoms but can carry out light work.
Have adequate organ functions, which include:
- Hematological (blood-related):
  - Absolute neutrophil count (ANC) >1.5 x 10⁹/L
  - Platelet count >100 x 10⁹/L
  - Hemoglobin > 6.2 mmol/L
- Hepatic (liver-related):
  - Bilirubin within normal range
  - Aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 times the upper normal limit
  - Albumin > 25 g/L
- Renal (kidney-related):
  - Creatinine clearance >30 mL/min/1.73m²

Who Cannot Join the Study?

Patients who do not have metastatic castration-resistant prostate cancer (mCRPC) 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.
Only male patients can participate. Female patients are not eligible.
Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Frederiksberg Hospital	Frederiksberg	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Ebastine is a medication that is typically used to treat allergies by blocking certain natural substances in the body that cause allergic reactions. In this clinical trial, it is being tested to see if it can help treat prostate cancer that has spread and is not responding to hormone therapy. Researchers are interested in how this medication might work with another cancer treatment to improve patient outcomes.

Docetaxel is a type of chemotherapy drug that is commonly used to treat various kinds of cancer, including prostate cancer. It works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of the disease. In this trial, docetaxel is being used in combination with another medication to see if this approach can be more effective in treating prostate cancer that has become resistant to other treatments.

Metastatic castration-resistant prostate cancer (mCRPC) – This is a form of prostate cancer that continues to progress despite treatments that lower testosterone levels. It is characterized by the spread of cancer cells to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells grow and multiply, often leading to increased levels of prostate-specific antigen (PSA) in the blood. Over time, the cancer may cause symptoms such as pain, fatigue, and urinary issues. The progression of mCRPC can vary, with some patients experiencing rapid advancement while others may have a slower course. The disease is typically monitored through imaging studies and PSA levels to assess its progression.

Trial ID:

2024-518035-11-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ebastine and Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer in Patients with Advanced Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?