Study on Radium-223, Docetaxel, and Prednisone for Patients with Bone-Only 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), which has spread to the bones and does not respond to hormonal therapy. The study is investigating the effects of different sequences of treatments using Radium-223, Docetaxel, and Prednisone. Radium-223 is a radioactive substance used to treat cancer that has spread to the bones, Docetaxel is a chemotherapy medication, and Prednisone is a steroid that helps reduce inflammation and suppress the immune system.

The purpose of the study is to understand how these treatments, when given in different orders, affect the quality of life of patients with this specific type of prostate cancer. Participants will receive these treatments over a period of time, and their health-related quality of life will be assessed at various stages. The study will also involve the use of a placebo in some cases to compare the effects of the actual treatments.

Throughout the study, participants will undergo regular assessments to monitor their health and the progression of the disease. The study aims to provide insights into the best treatment sequence for improving the quality of life in patients with bone-only metastatic castration-resistant prostate cancer. The trial is expected to continue until November 2025, with the goal of finding effective treatment strategies for this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Blood tests and imaging studies are performed to establish baseline health metrics and confirm the presence of bone metastases.

2 treatment phase 1

The first phase of treatment involves the administration of radium-223 and docetaxel.

Radium-223 is given as an injection once every four weeks for a total of six injections.

Docetaxel is administered as an intravenous infusion every three weeks. The dosage is determined based on individual health factors.

3 supportive medication

During the treatment, prednisone is taken orally. The typical dosage is 5 mg daily.

In some cases, dexamethasone may be prescribed to manage side effects. This can be taken as oral drops or as an injection, depending on the specific needs.

4 monitoring and assessments

Regular health assessments are conducted throughout the treatment to monitor progress and manage any side effects.

Quality of life and pain levels are evaluated using specific questionnaires at each treatment cycle and at the end of treatment.

5 treatment phase 2

Following the initial treatment phase, a second phase may involve adjustments to the treatment regimen based on individual response.

Further cycles of docetaxel may be administered, and additional supportive care is provided as needed.

6 follow-up

After completing the treatment phases, follow-up visits are scheduled to assess long-term health outcomes.

These visits include health evaluations and may involve additional imaging studies to monitor the status of bone metastases.

Who Can Join the Study?

Patients must have a confirmed diagnosis of prostate cancer through a test called histology or cytology.
Patients should have a life expectancy of more than 6 months.
Patients must have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Patients must have normal organ and bone marrow function, which includes having enough white blood cells, neutrophils, and platelets, and normal levels of bilirubin, liver enzymes (AST/ALT), and creatinine.
Male patients and their female partners who can have children must use two methods of birth control, including a condom, during the study and for 6 months after the last treatment.
Patients should not have had any other cancers in the past 5 years, except for certain skin cancers that have been successfully treated.
Patients must be willing and able to give informed consent to participate in the study.
Patients must have two or more bone metastases, which are cancer spots in the bones, confirmed by a bone scan within 8 weeks before starting the study.
Patients must have symptoms of the disease, such as needing regular pain medication or having received radiation therapy for bone pain in the last 12 weeks.
Patients must have castration-resistant disease, meaning their cancer continues to grow even when testosterone levels are very low.
Patients who have tried initial hormonal therapy must have stopped anti-androgen treatment for at least four weeks before being eligible.
Patients must have progressive disease, shown by increasing PSA levels or new bone lesions on a scan. PSA is a protein made by the prostate, and higher levels can indicate cancer growth.
Patients must have stopped treatment with certain drugs like ADT, abiraterone, or enzalutamide at least 4 weeks before starting the study.
Patients who previously received a drug called docetaxel for prostate cancer should only join if it has been more than 2 years since their last treatment with it.
Patients must be male and at least 18 years old.

Who Cannot Join the Study?

Patients who do not have metastatic castration resistant prostate cancer (mCRPC). 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 do not have symptomatic bone-only metastatic castration resistant prostate cancer (mCRPC). This means the cancer has spread only to the bones and is causing symptoms like pain.
Patients who are not male, as the study is only for male participants.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Central Hospital Of Bolzano	Bolzano	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Aodlehd Oguueoegxde Unbrxebsxngyy Pjybl	Parma	Italy
Ikvelzak Recjxkdul Pol Lg Snakeb Dvx Tzhlqu Dvft Asjlewt Ihmt Sqqiza	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.08.2017

Trial locations

Investigated drugs:

Radium-223 is a type of radiation therapy used to treat prostate cancer that has spread to the bones. It works by delivering targeted radiation to the bone tumors, helping to relieve pain and slow the growth of cancer cells in the bones.

Docetaxel is a chemotherapy medication used to treat various types of cancer, including prostate cancer. It works by interfering with the growth and spread of cancer cells in the body.

Prednisone is a corticosteroid medication often used in combination with other cancer treatments. It helps reduce inflammation and can improve the effectiveness of chemotherapy drugs like docetaxel.

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, often affecting bones, lymph nodes, or other organs. The disease is characterized by its resistance to hormonal therapy, which is typically used to manage prostate cancer. Patients may experience symptoms such as pain, fatigue, and urinary issues due to the spread of cancer. The progression of mCRPC can vary, with some patients experiencing rapid advancement while others may have a slower course. The focus is often on managing symptoms and maintaining quality of life.

Symptomatic Bone-Only Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This form of prostate cancer is similar to mCRPC but specifically involves metastasis to the bones without affecting other organs. Patients often experience significant bone pain and may be at risk for fractures or other skeletal complications. The disease progresses as cancer cells in the bone continue to grow despite low testosterone levels. Symptoms can include severe pain, reduced mobility, and other bone-related issues. Management typically focuses on alleviating pain and preventing further bone damage. The progression can lead to increased discomfort and challenges in daily activities.

Trial ID:

2024-511660-89-00

Protocol code:

IRST185.04

NCT ID:

NCT03230734

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Radium-223, Docetaxel, and Prednisone for Patients with Bone-Only Metastatic Castration-Resistant Prostate Cancer

What is this study about?

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