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

Verified siteRegistered drugNo placebo
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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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • Radium-223

    Radium-223 is administered intravenously and is currently used in the treatment of metastatic castration-resistant prostate cancer (mCRPC), particularly when the cancer has spread to the bones. It is recognized in medical literature as a targeted alpha therapy that delivers radiation directly to bone metastases, helping to relieve pain and improve quality of life. The mechanism of action involves the emission of alpha particles that cause double-strand breaks in DNA, leading to the death of cancer cells. Radium-223 is classified as a radiopharmaceutical.

  • Docetaxel

    Docetaxel is given through intravenous infusion and is widely used in the treatment of various cancers, including metastatic castration-resistant prostate cancer (mCRPC). It is well-documented in medical literature as a chemotherapy agent that disrupts cell division by stabilizing microtubules, preventing their disassembly, which ultimately leads to cell death. Docetaxel belongs to the pharmacological class of taxanes.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511660-89-00Protocol codeIRST185.04Estimated enrolment70 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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