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Study of Cabozantinib and Atezolizumab Compared to Hormonal Therapy in Adults with 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 study focuses on patients with metastatic castration-resistant prostate cancer, a condition where prostate cancer has spread to other parts of the body and continues to grow despite treatments that lower testosterone levels. The study compares two different treatment approaches: a combination of cabozantinib and atezolizumab versus second-line hormonal therapy using either abiraterone or enzalutamide.

The purpose of the study is to evaluate how well the combination of cabozantinib and atezolizumab works compared to hormonal therapy in patients who have previously received one type of hormonal treatment and whose cancer has spread beyond the pelvis. Cabozantinib is a medication that blocks certain proteins involved in cancer growth, while atezolizumab is an immunotherapy drug that helps the immune system fight cancer cells.

During the study, participants will receive either the combination treatment or one of the hormonal therapies. All medications will be taken as prescribed by the study doctor. Patients receiving cabozantinib and atezolizumab will take cabozantinib by mouth and receive atezolizumab through intravenous infusion. Those assigned to hormonal therapy will take either abiraterone or enzalutamide tablets by mouth along with prednisone, a steroid medication.

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

    Initial assessment

    Your eligibility for the study will be confirmed through laboratory tests checking your blood cell counts, liver function, and kidney function.

    A medical examination will verify that you have measurable cancer tissue outside the pelvic area.

    Your testosterone levels must be below 50 ng/dL.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Combination of cabozantinib (tablets) and atezolizumab (intravenous infusion)

    Group 2: Either abiraterone tablets with prednisone tablets, or enzalutamide tablets

  3. Step 3

    Treatment period

    You will continue taking the assigned medication until your condition shows progression or you experience significant side effects.

    Regular blood tests and imaging scans will monitor your response to treatment.

    Your doctor will check for any side effects during scheduled visits.

  4. Step 4

    Follow-up period

    After completing treatment, you must use effective birth control methods for:

    - 16 weeks after the last dose if you received cabozantinib and atezolizumab

    - 3 weeks after the last dose if you received abiraterone

    - 12 weeks after the last dose if you received enzalutamide

  5. Step 5

    Study completion

    The study is expected to continue until October 2026.

    Your participation will end if your condition progresses or you experience unacceptable side effects.

Who can join the trial?

15 criteria

  • Must be male with confirmed prostate adenocarcinoma (a type of prostate cancer) through tissue or cell examination
  • Must be at least 18 years old
  • Must be able to understand and follow study requirements, including visits, treatments, and tests
  • Must have signed an informed consent form before screening
  • If sexually active, must use effective contraception during the study and for up to 4 months after treatment ends, including barrier methods like condoms
  • Must have either increasing PSA (prostate-specific antigen) levels or cancer growth while on previous hormone therapy
  • Must have had surgical removal of testicles or be on ongoing hormone therapy with testosterone levels ≤ 50 ng/dL at screening
  • Must have measurable cancer spread outside the pelvis, either in organs or lymph nodes above the lower belly
  • Must show disease progression through either rising PSA levels or visible growth of tumors
  • Must have an ECOG performance status (measure of daily living abilities) of 0 or 1
  • Must have recovered from side effects of previous treatments
  • Must have adequate organ function, including:
    • Sufficient blood cell counts
    • Normal liver function tests
    • Adequate kidney function
    • Negative tests for hepatitis B and C

Who cannot join the trial?

14 criteria

  • Previous treatment with more than one hormone therapy (such as abiraterone, apalutamide, darolutamide, or enzalutamide)
  • Female patients (study is designed only for male participants)
  • Age under 18 years
  • Known brain or spinal cord metastases (cancer spread to brain or spine)
  • Active autoimmune disease requiring systemic treatment
  • History of severe allergic reactions to biological treatments
  • Significant heart problems or uncontrolled high blood pressure
  • Active or chronic hepatitis B or C infection
  • HIV positive status
  • Other active cancers in the past 3 years (except for adequately treated non-melanoma skin cancer)
  • Major surgery within 4 weeks before starting the study
  • Current participation in other clinical trials
  • Inability to swallow oral medications
  • Any condition that would make participation unsafe or compromise study compliance
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Investigated drugs

  • Cabozantinib

    is a medication that targets specific proteins in cancer cells to help stop them from growing and spreading. It works by blocking signals that cancer cells use to grow and create new blood vessels.

  • Atezolizumab

    is an immunotherapy medication that helps the body's immune system recognize and fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system.

  • Abiraterone

    is a hormone therapy medication used to treat prostate cancer. It works by stopping the body from producing testosterone, which can fuel prostate cancer growth.

  • Enzalutamide

    is also a hormone therapy medication for prostate cancer. It blocks testosterone from connecting with prostate cancer cells, which helps slow down or stop cancer growth.

  • Apalutamide

    is a hormone therapy medication that treats prostate cancer by preventing testosterone from helping cancer cells grow and spread.

  • Darolutamide

    is a hormone therapy medication used in prostate cancer treatment. It works by blocking the effects of testosterone on cancer cells.

What is already known about the treatment

  • Cabozantinib

    An oral tyrosine kinase inhibitor administered as tablets that targets multiple cancer pathways by blocking specific proteins involved in tumor growth and spread. This medication is used in the treatment of metastatic castration-resistant prostate cancer, working at the molecular level by inhibiting various receptors including MET, VEGFR2, and AXL. It belongs to the class of targeted cancer therapies and has shown effectiveness in clinical trials when combined with immunotherapy agents.

  • Atezolizumab

    An intravenously administered immunotherapy medication that belongs to the class of PD-L1 inhibitors, designed to help the immune system fight cancer cells. This monoclonal antibody works by blocking a protein called PD-L1 on cancer cells, which allows the body's T-cells to better recognize and attack tumor cells. It is being studied in combination with other cancer treatments for metastatic prostate cancer and has shown promising results in clinical trials.

  • Abiraterone

    An oral medication taken in tablet form that works by blocking the production of androgens (male hormones) throughout the body, including in the tumor tissue. This hormone therapy medication is used in treating metastatic castration-resistant prostate cancer by inhibiting an enzyme called CYP17, which is crucial for androgen production. It belongs to the class of novel hormonal therapies (NHT) and is typically administered in combination with prednisone.

  • Enzalutamide

    An oral anti-androgen medication that works by blocking the effects of testosterone and other male hormones in prostate cancer cells. This novel hormonal therapy (NHT) functions by preventing androgens from binding to their receptors, thereby inhibiting cancer cell growth and proliferation. It is used in the treatment of metastatic castration-resistant prostate cancer and is taken daily in capsule form.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer - A form of advanced prostate cancer that continues to grow despite treatments that lower testosterone levels in the body. In this condition, cancer cells have adapted to survive and multiply even when testosterone levels are very low. The cancer spreads (metastasizes) beyond the prostate to other parts of the body, commonly to bones, lymph nodes, or other organs. The disease typically develops progressively from earlier stages of prostate cancer, showing resistance to hormone therapy. The condition can affect multiple areas of the body simultaneously, with cancer cells forming new tumors in distant locations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516481-11-00Protocol codeXL184-315Estimated enrolment566 patientsSponsorExelixis Inc.

sourced from the EU Clinical Trials Register and site verification

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