Study Comparing Docetaxel Alone and Docetaxel with Radium-223 for Patients with 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 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 trial is comparing two treatment options: one group of patients will receive a medication called docetaxel, which is a common chemotherapy drug used to treat various cancers, including prostate cancer. The other group will receive a combination of docetaxel and another treatment called Radium-223, which is a radioactive substance used to target cancer cells in the bones.

The purpose of this study is to compare the overall survival of patients receiving docetaxel alone versus those receiving the combination of docetaxel and Radium-223. Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve regular visits to the clinic for treatment and monitoring. During these visits, doctors will assess the patient’s health and the progress of the cancer. The study will continue for a set period, and patients will be closely monitored throughout the process.

Radium-223 is administered as an injection into a vein, and it specifically targets cancer that has spread to the bones, which is common in advanced prostate cancer. The study aims to determine if adding Radium-223 to the standard treatment with docetaxel can improve survival outcomes for patients with mCRPC. Participants will receive support and care from the medical team throughout the study to ensure their safety and well-being.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where you will be asked to provide written informed consent. This consent allows the release of your personal health information for the study. It is important to understand all aspects of the study before signing.

During this visit, you will undergo a series of screening procedures to ensure you meet the study’s eligibility criteria. These may include blood tests and imaging scans to confirm your medical condition and overall health status.

2 randomization and treatment assignment

After the initial visit, you will be randomly assigned to one of two treatment groups. One group will receive docetaxel alone, while the other group will receive a combination of docetaxel and radium-223.

Randomization ensures that each participant has an equal chance of being assigned to either treatment group, which helps maintain the study’s scientific integrity.

3 treatment administration

If you are assigned to the docetaxel group, you will receive this medication through an intravenous (IV) infusion. The dosage and frequency will be determined by the study protocol and your healthcare provider.

If you are assigned to the combination group, you will receive both docetaxel and radium-223. Radium-223 is administered as a solution for injection, also through an IV. The specific dosage and schedule will be explained to you by the study team.

4 regular follow-up visits

Throughout the study, you will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and imaging scans.

The study team will assess your response to the treatment and any side effects you may experience. It is important to attend all scheduled visits and report any new symptoms or concerns to the study team.

5 quality of life assessments

During the study, you will be asked to complete questionnaires about your quality of life. These assessments will help the study team understand how the treatment affects your daily activities and overall well-being.

The questionnaires will be administered at specific intervals, including at the start of the study, during treatment, and after treatment has ended.

6 end of treatment and follow-up

Once you have completed the treatment phase, you will enter a follow-up period. During this time, the study team will continue to monitor your health and any long-term effects of the treatment.

Follow-up visits will occur at regular intervals, and you will be asked to continue completing quality of life assessments. This phase is crucial for understanding the long-term impact of the treatment.

Who Can Join the Study?

Must be willing and able to provide written permission to join the study and share personal health information.
Any side effects from previous treatments must have improved to a mild level or less.
Must be willing and able to follow the study rules, including attending follow-up visits and exams.
Must be a male aged 18 years or older.
Must have proof of prostate cancer through a tissue or cell sample.
Must have evidence of worsening metastatic castration-resistant prostate cancer (mCRPC) based on specific criteria, such as rising PSA levels, growth of soft-tissue tumors, or new bone lesions.
Must have at least two bone lesions as shown by a bone scan.
Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have normal organ function with acceptable lab test results within 14 days before starting the study.
Must agree to use a medically approved method of birth control or practice sexual abstinence during the study and for 6 months after the last dose of the study drug. Sperm donation is not allowed during this time.
Must have a serum testosterone level of less than 50 ng/dL and continue hormone therapy if they have not had surgical removal of the testicles.

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 considered part of a vulnerable population cannot participate. This means individuals who may not be able to give fully informed consent or who may be at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Amphia Hospital	Breda	The Netherlands
Tergooiziekenhuizen	Hilversum	The Netherlands
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Hospital Quironsalud Malaga	Malaga	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
Deventer Ziekenhuis	Deventer	The Netherlands
Medical Center Haaglanden	Leidschendam	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Ezjjyia Uigunkwjsyxe Mhshdke Cuimogu Rpiyvruxt (pdfzdzz Mqe	Rotterdam	The Netherlands
Hfidzqdm Vzmc dsspgnbg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	03.10.2019
The Netherlands	Not recruiting	03.10.2019

Trial locations

Investigated drugs:

Radium Ra 223 Dichloride

Docetaxel is a type of chemotherapy medication used to treat various cancers, 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 to see how well it works on its own compared to when it is combined with another treatment.

Radium-223 is a type of radiation therapy that targets cancer cells in the bones. It is used specifically for prostate cancer that has spread to the bones. Radium-223 works by delivering radiation directly to the bone tumors, which can help reduce pain and improve survival. In this trial, it is being combined with docetaxel to see if the combination is more effective than docetaxel alone.

Investigated diseases:

Hormone-refractory prostate cancer

Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It has spread to other parts of the body, such as bones or lymph nodes, beyond the prostate gland. The disease often progresses through the development of new tumors in these areas. Over time, the cancer cells may become less responsive to hormone therapy, leading to further growth and spread. The progression can involve increased pain, particularly in the bones, and other symptoms related to the areas affected by metastasis. As the disease advances, it can lead to complications such as fractures or other skeletal-related events.

Trial ID:

2024-513867-19-00

Protocol code:

c16-174

NCT ID:

NCT03574571

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Docetaxel Alone and Docetaxel with Radium-223 for Patients with Metastatic Castration-Resistant Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?