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Study on Capivasertib and Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer in Patients

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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). This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is testing a new treatment combination of two drugs: Capivasertib and Docetaxel. Capivasertib, also known by its code name AZD5363, is taken as a film-coated tablet, while Docetaxel is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to compare the effectiveness and safety of the combination of Capivasertib and Docetaxel against a combination of a placebo and Docetaxel in treating patients with mCRPC. A placebo is a substance with no active drug, used to compare the effects of the actual drug. Participants in the study will be randomly assigned to receive either the Capivasertib and Docetaxel combination or the placebo and Docetaxel combination. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual drug combination or the placebo combination.

Throughout the study, participants will receive regular treatments and will be monitored closely by the research team. The main goal is to assess the overall survival of patients, which refers to the length of time from the start of the study until death from any cause. The study will also look at other factors such as the progression of the cancer, changes in pain levels, and any side effects experienced by the participants. The study is expected to continue until December 2026, with the aim of providing valuable information on the potential benefits of Capivasertib in combination with Docetaxel for treating mCRPC.

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, the patient will be randomly assigned to one of two groups: one receiving capivasertib and docetaxel, and the other receiving a placebo and docetaxel.

    The study is designed to assess the effectiveness and safety of these treatments for metastatic castration-resistant prostate cancer.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with docetaxel, administered as an intravenous infusion. This will occur every three weeks.

    In addition, the patient will take capivasertib or a placebo orally, in the form of film-coated tablets, twice daily for four days each week.

  3. Step 3

    Treatment continuation

    The treatment with docetaxel and either capivasertib or placebo will continue for the duration of the study, unless the patient experiences unacceptable side effects or the disease progresses.

    Regular assessments will be conducted to monitor the patient's health and response to the treatment.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient will undergo various assessments to evaluate the effectiveness of the treatment. These may include imaging tests, blood tests, and evaluations of pain and physical functioning.

    The primary goal is to measure overall survival, while secondary goals include monitoring disease progression and quality of life.

  5. Step 5

    Completion of the study

    The study is expected to conclude by December 2026. At this point, the final data will be collected and analyzed to determine the outcomes of the treatment.

    The patient will receive information about the results and any further steps, if applicable.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer, without having a major presence of other types like neuroendocrine or small cell cancers.
  • Must be able and willing to swallow and keep oral medication.
  • Must agree to either not engage in heterosexual intercourse or use birth control methods, and also agree not to donate sperm.
  • Must have evidence of cancer that has spread to other parts of the body, shown by at least one bone lesion (a spot on the bone that shows up on a scan) or at least one soft tissue lesion (a growth that can be measured or not measured).
  • Must have been treated with a newer type of hormonal therapy for prostate cancer, such as abiraterone, enzalutamide, apalutamide, or darolutamide, for at least 3 months and shown signs of the disease getting worse during this treatment.
  • Must show evidence of **metastatic castration-resistant prostate cancer (mCRPC)**, which means the cancer is still progressing despite treatments that lower testosterone.
  • Must have a serum testosterone level of 50 ng/dL or lower.
  • Must be a suitable candidate for treatment with docetaxel, a type of chemotherapy, and steroid therapy.
  • Must be continuing androgen deprivation therapy (ADT), which is a treatment to lower male hormones, using either LHRH agonist, LHRH antagonist, or having had both testicles removed (bilateral orchiectomy).
  • Must have a performance status of 0 to 1 according to the **Eastern Cooperative Oncology Group (ECOG)** or **World Health Organisation (WHO)**, which means being fully active or having some symptoms but still able to carry out light work, and must have a life expectancy of at least 12 weeks.
  • Must have a sample of the tumor tissue that was preserved in a specific way (formalin-fixed paraffin embedded) available to send to a central laboratory for testing.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer other than Metastatic Castration Resistant Prostate Cancer (mCRPC). This is a specific type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are female, 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

  • Capivasertib

    is a medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested in combination with another drug to see if it can improve survival rates in patients with this type of cancer.

  • Docetaxel

    is a chemotherapy drug commonly used to treat various types of cancer, including prostate cancer. In this study, it is used in combination with capivasertib to evaluate if the combination is more effective than using docetaxel alone.

What is already known about the treatment

  • Capivasertib

    Capivasertib is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for capivasertib is mCRPC, where it is being evaluated for its potential to improve overall survival when combined with docetaxel. At the molecular level, capivasertib works by inhibiting specific enzymes involved in cancer cell growth and survival, particularly targeting the AKT pathway. It is classified as a kinase inhibitor in pharmacology.

  • Docetaxel

    Docetaxel is administered intravenously and is a well-established chemotherapy medication used in the treatment of various cancers, including metastatic castration-resistant prostate cancer (mCRPC). It is widely recognized in medical literature and is part of standard treatment regimens for certain cancer types. The main therapeutic indication for docetaxel in this context is mCRPC, where it is used to help control cancer growth and improve survival. Docetaxel works by disrupting the normal function of microtubules in cancer cells, which are essential for cell division, leading to cell death. It is classified as a taxane-based chemotherapy agent.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – 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, making it metastatic. The cancer cells in this condition are resistant to hormonal therapy, which is typically used to control prostate cancer. As the disease progresses, patients may experience symptoms such as bone pain, urinary issues, and fatigue. The progression of the disease can lead to further complications, including skeletal-related events and increased pain. The focus of treatment is often on managing symptoms and slowing the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504996-26-00Protocol codeD361EC00001Estimated enrolment1 375 patientsSponsorAstraZeneca AB

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