Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study Comparing Docetaxel and Androgen Receptor-Targeted Agents (Abiraterone or Enzalutamide) for Patients with Metastatic Castration-Resistant Prostate Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for metastatic castration-resistant prostate cancer (mCRPC), a type 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 comparing two different treatment approaches for patients with this condition. One group of patients will receive Docetaxel, a chemotherapy drug given through an intravenous infusion, along with prednisone, a steroid medication. The other group will receive an Androgen Receptor-targeted agent, which could be either Abiraterone or Enzalutamide, both taken orally, also in combination with prednisone.

The purpose of the study is to determine if Docetaxel is more effective than the Androgen Receptor-targeted agents in treating patients with mCRPC who do not have mutations in the BRCA1/2 genes or whose mutation status is unknown. The study will look at how long patients live without their cancer getting worse, known as progression-free survival, and will also compare the overall survival rates and the safety of the treatments. Additionally, the study will assess the quality of life of patients using questionnaires designed to measure health-related quality of life.

Participants in the study will be randomly assigned to one of the two treatment groups and will receive their assigned treatment for a period of time. The study will monitor the patients' health and response to the treatment through regular check-ups and tests. The trial aims to provide valuable information on the best first-line treatment options for patients with mCRPC who have certain adverse prognostic factors, which are characteristics that may predict a worse outcome for the patient.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive docetaxel or an androgen receptor-targeted agent such as abiraterone or enzalutamide.

  2. Step 2

    Treatment with docetaxel

    If assigned to the docetaxel group, you will receive this medication through an intravenous infusion. This means the medication will be administered directly into your vein. You will also take prednisone orally. The treatment cycle is typically every three weeks, but your doctor will provide specific instructions.

  3. Step 3

    Treatment with androgen receptor-targeted agent

    If assigned to the androgen receptor-targeted agent group, you will take either abiraterone or enzalutamide orally. You will also take prednisone orally. The dosage and frequency will be explained by your doctor, and you will follow this regimen as directed.

  4. Step 4

    Regular monitoring

    Throughout the study, you will have regular appointments to monitor your health and the effectiveness of the treatment. This will include blood tests, imaging scans, and other assessments as needed. Your doctor will inform you about the schedule and any preparations required for these tests.

  5. Step 5

    Completion of the study

    The study is expected to last until April 2027. Upon completion, you will have a final assessment to evaluate your health status and the outcomes of the treatment. Your doctor will discuss the results with you and provide guidance on any further steps or treatments if necessary.

Who can join the trial?

24 criteria

  • Willing and able to provide written informed consent.
  • Have adequate blood and chemistry values, which means:
    • Hemoglobin (a protein in red blood cells) of at least 10.0 g/dL without needing a blood transfusion.
    • Neutrophil count (a type of white blood cell) of at least 1500 x 109/L.
    • Platelet count (cells that help with blood clotting) of at least 100,000/μL.
    • Serum albumin (a protein in the blood) of at least 3.5 g/dL.
    • Serum creatinine (a waste product in the blood) less than 1.5 times the upper limit of normal, or a calculated creatinine clearance of at least 60 mL/min.
    • Serum potassium (an important mineral) of at least 3.5 mmol/L.
    • Liver function tests showing:
      • Serum bilirubin (a substance made by the liver) less than 1.5 times the upper limit of normal, except for patients with Gilbert’s disease.
      • AST or ALT (enzymes that indicate liver health) less than 2.5 times the upper limit of normal.
      • Able to swallow the study drug whole as a tablet.
      • Life expectancy of at least 6 months.
      • If you have a partner who can become pregnant, you must agree to use a method of birth control with adequate barrier protection during the study and for 13 weeks after the last dose of the study drug.
      • Male aged 18 years and above.
      • Have prostate cancer confirmed by a tissue sample.
      • Have cancer that has spread to other parts of the body, as shown by a bone scan or other imaging tests like CT or MRI. If the cancer has only spread to lymph nodes, the lymph nodes must be at least 2 cm in size. Alternatively, the spread can be confirmed by PET-Choline or PSMA scans.
      • Prostate cancer progression documented by PSA (a protein produced by the prostate) according to specific guidelines or by imaging tests.
      • Have at least one negative prognostic feature, such as:
        • Mildly symptomatic prostate cancer with a pain score of 2 or 3 on a specific pain scale.
        • Asymptomatic prostate cancer with a pain score of 0 or 1 and at least one of the following:
          • PSA level of 80 ng/dL or higher.
          • Gleason Score (a grading system for prostate cancer) of 8 or higher.
          • PSA doubling time of 3 months or less.
          • Time from starting hormone therapy to castration-resistant prostate cancer of less than 1 year.
          • No evidence of mutation in BRCA1 or BRCA2 genes, or tumor tissue not evaluated for quality reasons (status unknown).
          • Surgically or medically castrated, with testosterone levels of less than 50 ng/dL (less than 2.0 nM).
          • ECOG Performance Status (a scale to assess how a disease affects daily living abilities) of 0 or 2.

Who cannot join the trial?

3 criteria

  • Patients with metastatic castration-resistant prostate cancer that have mutations in the BRCA1/2 genes cannot participate. If the status of these genes is unknown, participation is also not allowed.
  • Only male patients can participate in the study.
  • Patients who are part of a vulnerable population are not eligible. This means individuals who may have limited ability to give informed consent or are at higher risk of harm.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Docetaxel

    is a type of chemotherapy medication used to treat various types of cancer. In this clinical trial, it is being tested to see if it is more effective than other treatments for patients with a specific type of prostate cancer. Docetaxel works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of the cancer.

  • Abiraterone

    is a medication used to treat prostate cancer by lowering the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so by reducing them, abiraterone can help slow down the progression of the disease. In this trial, it is combined with another medication to see how well it works compared to other treatments.

  • Prednisone

    is a steroid that is often used alongside other cancer treatments. It helps reduce inflammation and can also help manage some of the side effects of cancer treatment. In this trial, prednisone is used together with abiraterone to see if this combination is effective in treating prostate cancer.

  • Enzalutamide

    is another medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. This trial is testing enzalutamide to see if it is a better option compared to other treatments for patients with a certain type of prostate cancer.

What is already known about the treatment

  • Docetaxel

    Docetaxel is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently used in medicine to treat various types of cancer, including prostate cancer, and is well-documented in medical literature. The main therapeutic indication for docetaxel in this trial is metastatic castration-resistant prostate cancer (mCRPC) without BRCA1/2 mutations or unknown status. At the molecular level, docetaxel works by interfering with the normal function of microtubules, which are structures that help cells divide, thereby preventing cancer cells from multiplying. It is classified as a chemotherapy drug, specifically a taxane.

  • Abiraterone

    Abiraterone is taken orally in pill form, usually alongside prednisone, a steroid. It is widely recognized in medical literature and used to treat prostate cancer, particularly in cases where the cancer has spread and is resistant to traditional hormone therapy. The main therapeutic indication in this trial is metastatic castration-resistant prostate cancer (mCRPC) without BRCA1/2 mutations or unknown status. Abiraterone works by blocking the production of androgens, which are hormones that can promote the growth of prostate cancer cells. It is classified as an androgen biosynthesis inhibitor.

  • Enzalutamide

    Enzalutamide is administered orally in capsule form. It is well-established in medical literature and used to treat prostate cancer, especially when the cancer has spread and is resistant to other hormone therapies. The main therapeutic indication in this trial is metastatic castration-resistant prostate cancer (mCRPC) without BRCA1/2 mutations or unknown status. Enzalutamide works by blocking the action of androgens, which are hormones that can stimulate the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – 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 beyond the prostate gland to other parts of the body, such as bones or lymph nodes. The disease progresses as cancer cells grow and multiply, often leading to increased symptoms such as pain or difficulty urinating. Over time, the cancer may become resistant to hormone therapy, which is initially used to control its growth. As the disease advances, it can lead to more severe symptoms and complications due to the spread of cancerous cells. The progression of this cancer is typically monitored through imaging tests and blood markers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518623-30-00Protocol codeRADAR-1 CRPCEstimated enrolment68 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.