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Study of AZD5305 with Abiraterone Acetate and Darolutamide in Men with Metastatic Castration-Sensitive Prostate Cancer

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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 condition known as Metastatic Castration-Sensitive Prostate Cancer (mCSPC). This is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone levels. The study will explore the effectiveness of a new treatment called AZD5305, which will be used in combination with other hormonal treatments chosen by the patient's doctor. These hormonal treatments include medications like ZYTIGA (abiraterone acetate), NUBEQA (darolutamide), and Xtandi (enzalutamide). The study will also involve a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to determine if the combination of AZD5305 and the chosen hormonal treatments is more effective than the placebo in preventing the cancer from getting worse, as seen on imaging tests like CT or MRI scans. Participants in the study will be randomly assigned to receive either the new treatment or the placebo, along with their doctor's choice of hormonal therapy. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

The study will last for a period of time, during which participants will take the medication orally in the form of tablets. Regular check-ups and imaging tests will be conducted to monitor the progress of the disease and the effectiveness of the treatment. The main goal is to see if the new treatment can help patients live longer without their cancer getting worse. The study will also look at other outcomes, such as overall survival and the time it takes for the cancer to become resistant to treatment.

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 participant is assigned to one of two groups: one receiving the experimental drug AZD5305 in combination with a new hormonal agent, and the other receiving a placebo with a new hormonal agent.

    The assignment is random and neither the participant nor the study team knows which group the participant is in.

  2. Step 2

    Medication administration

    Participants take the assigned medication orally. The specific medication and dosage depend on the group assignment.

    The experimental drug AZD5305 or the placebo is taken in combination with a new hormonal agent chosen by the physician. Options for the hormonal agent include ZYTIGA (abiraterone acetate) 250 mg or 500 mg tablets, NUBEQA (darolutamide) 300 mg film-coated tablets, or Xtandi (enzalutamide) 40 mg film-coated tablets.

    The frequency and duration of administration are determined by the study protocol and the physician's choice.

  3. Step 3

    Monitoring and assessments

    Participants undergo regular monitoring to assess the effectiveness of the treatment. This includes imaging tests such as CT or MRI scans to evaluate the progression of the cancer.

    Blood samples are collected to monitor health and response to treatment. Tumor tissue samples may also be required for specific assessments.

  4. Step 4

    Follow-up and evaluation

    The primary goal is to measure radiographic progression-free survival, which is the time until the cancer shows signs of progression on imaging tests or until death from any cause.

    Secondary goals include overall survival, time to second progression or death, and other clinical outcomes related to the cancer and quality of life.

  5. Step 5

    Completion of the study

    The study is estimated to end by April 2031. Participants continue to be monitored until the study concludes or until they meet criteria for discontinuation.

    Upon completion, participants may receive information about the group they were in and the overall results of the study.

Who can join the trial?

10 criteria

  • Must be a male who is 18 years of age or older.
  • Must use a condom from the time of signing the informed consent form (ICF), during the study, and for 6 months after the last dose of the study drug, with all sexual partners.
  • Must have a type of prostate cancer called **prostate adenocarcinoma** that is either new or has come back and is **castration-sensitive**. This means the cancer responds to treatments that lower testosterone. Cannot have certain types of cancer cells like small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell.
  • Must have **metastatic disease**, meaning the cancer has spread to other parts of the body, with at least one bone lesion or one soft tissue lesion that can be checked with CT or MRI scans.
  • Must be receiving **ADT** (Androgen Deprivation Therapy) with a **GnRH analogue** (a type of hormone therapy) or have had both testicles removed (bilateral orchiectomy) starting at least 14 days and less than 4 months before joining the study.
  • Must have an **ECOG performance status** of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work, with no worsening in the 2 weeks before joining the study.
  • Must provide a sample of the tumor tissue and a blood sample for testing.
  • Must have a confirmed **HRRm status**, which involves specific genetic testing of the tumor tissue or blood to determine eligibility for the study group.
  • Must have adequate organ and bone marrow function as described in the study protocol.
  • Must agree not to father children or donate sperm from the time of signing the ICF, during the study, and for 6 months after the last dose of the study drug.

Who cannot join the trial?

4 criteria

  • Patients who are not male cannot participate.
  • Patients who do not have **Metastatic Castration-Sensitive Prostate Cancer (mCSPC)** cannot participate. This is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • AZD5305

    is an experimental medication being studied for its potential to treat prostate cancer. It is being tested in combination with other hormonal treatments to see if it can help slow down the progression of the disease in patients with metastatic castration-sensitive prostate cancer.

  • New Hormonal Agents (NHA)

    are medications chosen by the patient's doctor that are used to treat prostate cancer by targeting hormones that fuel cancer growth. These agents are part of the standard treatment options and are used in combination with the experimental medication AZD5305 in this study.

What is already known about the treatment

AZD5305 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-sensitive prostate cancer. It is in the experimental phase and not yet approved for general medical use. The main therapeutic indication is to improve radiographic progression-free survival in patients with this type of prostate cancer. AZD5305 works by targeting specific molecular pathways involved in cancer cell growth, potentially inhibiting tumor progression. It is classified as a targeted therapy, focusing on specific genetic mutations associated with cancer.

Investigated diseases

Metastatic Castration-Sensitive Prostate Cancer (mCSPC) – This is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone levels. The disease begins in the prostate gland and can metastasize to bones, lymph nodes, or other organs. In its castration-sensitive stage, the cancer cells are still dependent on androgens, such as testosterone, for growth. As the disease progresses, it may become resistant to hormone therapy, leading to more aggressive growth. Patients may experience symptoms related to the spread of cancer, such as bone pain or urinary issues. The progression of the disease is often monitored through imaging studies to assess changes in tumor size or spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504214-30-00Protocol codeD9723C00001Estimated enrolment1 805 patientsSponsorAstraZeneca AB

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