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Study on the Effectiveness and Safety of Apalutamide and Stereotactic Radiotherapy for Patients with High-Risk Localized or Locally Advanced Prostate Cancer

InvestigationalNo placebo
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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 prostate cancer, specifically cases that are either localized or locally advanced and considered high-risk. The treatment being tested involves a combination of Androgen Deprivation Therapy (ADT), a medication called apalutamide, and a type of precise radiation treatment known as stereotactic radiotherapy. The purpose of the study is to evaluate how effective and safe this combination treatment is for patients with high-risk prostate cancer.

Participants in the study will receive the treatment over a period of time, and their health will be monitored to see how well the cancer is controlled and to check for any side effects. The study will look at how many patients remain free of cancer progression after five years and will also assess the safety of the treatment by monitoring for any significant side effects related to the digestive and urinary systems. The study aims to provide valuable information on the long-term outcomes of this treatment approach, including survival rates and quality of life for patients.

The trial will continue until 2031, with participants being followed up to assess the long-term effects of the treatment. The study will also explore the impact of the treatment on patients' quality of life, using various questionnaires to gather information on their well-being. This research is important for understanding how to best treat high-risk prostate cancer and improve outcomes for patients.

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 required to sign an informed consent form. This form confirms that you understand the purpose and procedures of the study and agree to participate.

    You must be between 18 and 79 years old and have a confirmed diagnosis of localized or locally advanced high-risk prostate cancer.

  2. Step 2

    Initial assessments

    Before starting treatment, several assessments will be conducted to ensure eligibility. These include blood tests to check organ function and imaging tests like MRI or CT scans to assess the stage of cancer.

    You will also undergo a performance status evaluation to determine your ability to perform daily activities.

  3. Step 3

    Treatment phase

    The treatment phase involves a combination of therapies. You will take a medication called apalutamide orally. The dosage and frequency will be determined by the study team.

    In addition to medication, you will receive stereotactic radiotherapy, a type of targeted radiation treatment for prostate cancer.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment.

    These visits will include physical exams, blood tests, and imaging studies to track the progress of the cancer and any side effects from the treatment.

  5. Step 5

    End of treatment

    After completing the treatment phase, you will continue to be monitored for a period of time to assess long-term outcomes.

    The study aims to evaluate the 5-year biochemical control rate, which measures the effectiveness of the treatment in preventing cancer progression.

Who can join the trial?

15 criteria

  • The participant must be a man aged between 18 and 79 years.
  • The participant must sign a form to show they understand the study and agree to take part.
  • The participant should be scheduled to receive primary radiation therapy for prostate cancer.
  • The participant must have a confirmed diagnosis of prostate cancer with certain risk factors, such as:
    • PSA (a protein produced by the prostate) level greater than 20 ng/mL.
    • Gleason Score greater than 7, which is a grading system for prostate cancer.
    • Specific clinical stages of cancer, determined by medical exams like digital rectal examination or imaging tests.
    • The participant must have a Modified Charlson Comorbidity Index of 4 or less, which is a score that predicts the ten-year mortality for a patient who may have a range of comorbid conditions.
    • The participant must have an ECOG performance status of 0 or 1, which is a scale used to assess how a patient's disease is progressing and how the disease affects the daily living abilities of the patient.
    • The participant must have adequate organ function, as shown by specific laboratory tests:
      • AST and ALT (liver enzymes) levels no more than 2.5 times the upper limit of normal.
      • Total bilirubin no more than 1.5 times the upper limit of normal.
      • Serum creatinine no more than 2 times the upper limit of normal.
      • Thrombocytes (platelets) at least 140x109/L.
      • Hemoglobin at least 120 g/L, without blood transfusion in the last 3 months.
      • To prevent drug exposure through semen, participants must use a condom during sexual activity while on the study drug and for 3 months after the last dose. Sperm donation is not allowed during this time.
      • The participant must be able to swallow whole tablets, undergo prostate MRI, have prostate seeds implanted, and receive prostate radiotherapy while lying on their back.

Who cannot join the trial?

3 criteria

  • Patients who do not have localized or locally advanced high-risk prostate cancer cannot participate.
  • Only male patients are eligible for the study.
  • Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Apalutamide

    is a medication used in this clinical trial to help treat prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down or stop the growth of cancer cells. In this study, apalutamide is combined with other treatments to see if it can improve the control of prostate cancer and reduce the risk of the disease getting worse.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones in the body, which can help slow the growth of prostate cancer. This therapy is often used in combination with other treatments to enhance its effectiveness. In this trial, ADT is used alongside apalutamide and stereotactic radiotherapy to assess its impact on prostate cancer.

  • Stereotactic Radiotherapy

    is a type of radiation therapy that precisely targets cancer cells in the prostate. It uses advanced technology to deliver high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. This therapy is part of the trial to determine if it can improve the treatment outcomes for patients with high-risk prostate cancer when used with apalutamide and ADT.

What is already known about the treatment

Apalutamide – Apalutamide is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating localized or locally advanced high-risk prostate cancer. It is primarily used to help manage prostate cancer by blocking the action of male hormones that can promote cancer growth. At the molecular level, apalutamide works by attaching to androgen receptors, preventing them from activating the genes that help cancer cells grow. It is classified as an anti-androgen medication, which means it helps reduce the effects of male hormones in the body.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins as a localized condition, meaning it is confined to the prostate gland. As it progresses, it can become locally advanced, spreading to nearby tissues or organs. High-risk prostate cancer indicates a greater likelihood of spreading or recurring. The progression of the disease can be monitored through levels of prostate-specific antigen (PSA) in the blood. Biochemical progression is marked by a significant rise in PSA levels, indicating that the cancer may be advancing.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517901-97-00Protocol code56021927PCR2046Estimated enrolment48 patientsSponsorVychodoslovensky Onkologicky Ustav a.s.

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