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Study on Shortened Treatment with Apalutamide and Enzalutamide for Patients with Low-Volume 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 type of prostate cancer known as low-volume metastatic castration-sensitive prostate cancer. This condition refers to prostate cancer that has spread to other parts of the body but is still responsive to treatments that lower testosterone levels. The study will explore the effects of two medications, apalutamide and enzalutamide, which are known as androgen receptor signaling inhibitors (ARSIs). These medications work by blocking the effects of male hormones that can promote the growth of prostate cancer cells.

The purpose of the study is to determine if stopping the use of ARSIs after 12 months, with the option to restart if necessary, is as effective as continuing the treatment without interruption. This approach aims to reduce the side effects and costs associated with prolonged medication use. Participants in the study will receive either apalutamide or enzalutamide, along with standard hormone therapy, for a total period of 12 months. Some participants will continue the treatment beyond this period, while others will stop and be monitored for any changes in their condition.

Throughout the study, participants will undergo regular check-ups to monitor their health and the progression of their cancer. The study will assess various outcomes, including the time it takes for the cancer to progress, overall survival rates, and the impact of treatment on quality of life. The study will also explore the relationship between certain genetic markers and treatment outcomes, using advanced imaging techniques like PSMA-PET scans to gather detailed information about the cancer's behavior. The trial is expected to run until 2029, providing valuable insights into the management of this type of prostate cancer.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and disease volume.

    The study focuses on patients with low-volume metastatic castration-sensitive prostate cancer.

  2. Step 2

    Initial treatment phase

    Treatment begins with androgen deprivation therapy (ADT) using medications like leuprorelin acetate, goserelin acetate, or triptorelin.

    These medications are administered through subcutaneous injection, implantation, or intramuscular injection, depending on the specific drug.

  3. Step 3

    Androgen receptor signaling inhibitor (ARSI) therapy

    Patients receive an androgen receptor signaling inhibitor (ARSI) such as apalutamide or enzalutamide.

    These medications are taken orally and are part of the combination therapy with ADT.

  4. Step 4

    Treatment duration

    The ARSI therapy is administered for a duration of 12 months.

    The objective is to evaluate the effects of discontinuing ARSI after this period while continuing ADT.

  5. Step 5

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to assess clinical progression-free survival and overall survival.

    Additional evaluations include time to PSA increase, quality of life assessments, and correlation of imaging and genomic data with clinical outcomes.

  6. Step 6

    Potential treatment restart

    If necessary, there is a possibility to restart ARSI treatment based on the patient's condition and study findings.

    The study aims to determine if discontinuing ARSI after 12 months is as effective as continued treatment, with the goal of reducing side effects and costs.

Who can join the trial?

6 criteria

  • Must be a male and at least 18 years old.
  • Must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer.
  • Must have low-volume metastatic disease, meaning the cancer has spread but not extensively. This is determined by specific scans like a bone scan, CT scan, or PSMA-PET scan, and confirmed by a medical team.
  • Must not have started ADT treatment yet. ADT stands for androgen deprivation therapy, a treatment to lower male hormones.
  • Must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Must be considered fit for treatment with apalutamide or enzalutamide by the treating doctor. These are medications used to treat prostate cancer.

Who cannot join the trial?

4 criteria

  • Patients who do not have low-volume metastatic castration-sensitive prostate cancer. This means the cancer has spread to other parts of the body but is still responsive to treatments that lower testosterone.
  • Patients who are not male, as the study is only for male participants.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

  • Apalutamide

    is a medication used in this trial to block the effects of male hormones that can promote the growth of prostate cancer cells. It is part of a group of drugs known as androgen receptor signaling inhibitors (ARSIs). The trial is investigating whether stopping this medication after 12 months is as effective as continuing it for a longer period in patients with low-volume metastatic castration-sensitive prostate cancer.

  • Enzalutamide

    is another medication used in the trial, similar to Apalutamide, which also works by blocking the effects of male hormones on prostate cancer cells. It is used in combination with other therapies to manage prostate cancer and is being studied to see if its discontinuation after 12 months is non-inferior to ongoing treatment in terms of effectiveness and reducing side effects.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones in the body to slow down or stop the growth of prostate cancer. In this trial, it is used in combination with androgen receptor signaling inhibitors to treat patients with low-volume metastatic castration-sensitive prostate cancer. The study aims to determine if stopping the ARSIs after 12 months while continuing ADT is a viable treatment strategy.

What is already known about the treatment

  • Apalutamide

    Apalutamide is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating low-volume metastatic castration-sensitive prostate cancer. The main therapeutic indication is to inhibit the growth of prostate cancer cells by blocking the action of androgens, which are male hormones that can promote tumor growth. At the molecular level, apalutamide works by binding to androgen receptors, preventing them from activating the genes that drive cancer cell proliferation. It is classified as an androgen receptor inhibitor.

  • Enzalutamide

    Enzalutamide is taken orally as a capsule. It is under investigation in clinical trials for its role in managing low-volume metastatic castration-sensitive prostate cancer. The primary therapeutic use is to slow down or stop the growth of prostate cancer by interfering with the effects of androgens. Enzalutamide functions by binding to androgen receptors, blocking the signals that tell cancer cells to grow and divide. It belongs to the pharmacological class of androgen receptor inhibitors.

Investigated diseases

Low-volume metastatic castration-sensitive prostate cancer – This is a type of prostate cancer that has spread to other parts of the body but remains responsive to treatments that lower testosterone levels. The term "low-volume" indicates that the cancer has not spread extensively, typically involving fewer than four bone lesions and no visceral metastases. The disease progresses as cancer cells continue to grow and spread, but the pace can vary among individuals. It remains sensitive to hormone therapy, which can help control the growth of cancer cells. Over time, the cancer may become resistant to hormone therapy, leading to a more advanced stage known as castration-resistant prostate cancer. Monitoring and managing the disease involves regular assessments to track its progression and response to treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506698-36-00Estimated enrolment400 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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