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Study on Adding Apalutamide to Radiotherapy and LHRH Agonist for High-Risk Patients with Hormone-Sensitive 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 clinical trial is focused on studying a treatment for high-risk hormone-sensitive prostate cancer. The study is investigating the effectiveness and safety of adding a medication called Apalutamide to a combination of radiotherapy and a type of hormone therapy known as LHRH agonist. The goal is to see if this combination can delay the spread of cancer or death compared to using just radiotherapy and LHRH agonist alone. The study will use a special imaging technique called PSMA-PET to assess the cancer's progression.

Participants in the study will receive either the combination of Apalutamide, radiotherapy, and LHRH agonist or just radiotherapy and LHRH agonist. The study will also include an observational group to gather additional information. Apalutamide is taken as a tablet by mouth, while radiotherapy is a treatment that uses high-energy rays to target cancer cells. The LHRH agonist is a type of hormone therapy that is given as an injection under the skin. The study will monitor participants over a period to observe the effects of the treatments.

The study aims to provide valuable insights into whether adding Apalutamide can improve outcomes for patients with high-risk hormone-sensitive prostate cancer. By using PSMA-PET, a type of imaging that helps visualize prostate cancer, researchers hope to better understand how the cancer responds to the treatment. This trial is an important step in exploring new ways to manage and treat prostate cancer effectively.

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 will have signed an informed consent form, indicating understanding and willingness to participate in the study.

    The participant must be 18 years or older and have a confirmed diagnosis of high-risk recurrent prostate cancer previously treated with radical prostatectomy.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility, including a review of medical history and current health status.

    The participant must have adequate organ function and be able to swallow the study drug tablets or follow instructions for admixing with apple sauce.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of apalutamide in combination with radiotherapy and LHRH agonist.

    Apalutamide is provided in the form of film-coated tablets for oral use. The dosage and frequency will be determined by the study protocol.

    Participants receiving bone-loss prevention treatment must be on stable doses for at least 4 weeks before randomization.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess the participant's response to treatment and any side effects.

    The primary endpoint is PSMA-PET metastatic progression-free survival, which is the time from randomization to the date of metastatic progression or death from any cause.

  5. Step 5

    End of treatment

    The treatment phase will conclude as per the study protocol, and participants will be monitored for a specified period after the last dose of the study drug.

    Participants must agree not to donate sperm for reproduction during the treatment phase and for a minimum of 3 months after the last dose.

Who can join the trial?

18 criteria

  • Must be a person aged 18 years or older.
  • Must have adequate organ function, which means:
    • Levels of certain liver enzymes (AST and ALT) should be no more than 2.5 times the normal limit.
    • Total bilirubin, a substance made by the liver, should be no more than 1.5 times the normal limit.
    • Serum creatinine, a waste product in the blood, should be less than 1.8 mg/dL.
    • Platelets, which help with blood clotting, should be at least 75,000 per microliter without recent transfusions or growth factors.
    • Hemoglobin, a protein in red blood cells, should be at least 10.0 g/dL without recent transfusions or growth factors.
    • Must be able to swallow the study drug tablets or mix them with applesauce.
    • If engaging in sexual activity with a person who can become pregnant, a condom must be used along with another effective birth control method during the treatment and for 3 months after the last dose.
    • Must agree not to donate sperm for reproduction during the treatment and for at least 3 months after the last dose.
    • If receiving treatment to prevent bone loss, must be on stable doses for at least 4 weeks before starting the study.
    • Must be planned to receive a specific type of radiation therapy for prostate cancer.
    • Must sign an Informed Consent Form, showing understanding and willingness to participate in the study.
    • Must have a confirmed diagnosis of prostate cancer.
    • Must have been previously treated with a surgery called radical prostatectomy, with specific conditions related to PSA levels, a protein produced by the prostate.
    • Must be at high risk of cancer spreading, based on certain medical criteria like a high Gleason score, which is a grading system for prostate cancer.
    • Results from a specific scan called PSMA-PET must meet certain conditions regarding cancer lesions.
    • If there is evidence of cancer spread on a PSMA-PET scan, there must be no evidence of spread on other scans like CT, MRI, or bone scans. If a single bone lesion is found, it must be confirmed by another scan.
    • Must have a performance status of Grade 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.

Who cannot join the trial?

3 criteria

  • Patients who have not been diagnosed with high risk recurrent prostate cancer that was previously treated with surgery to remove the prostate.
  • Patients who are female, as the study is only for male participants.
  • Patients who are part of 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 treat high-risk patients with hormone-sensitive prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. The study aims to see if adding apalutamide to the standard treatment can delay the spread of cancer or death.

  • Radiotherapy (RT)

    is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used as part of the standard treatment for prostate cancer to help control the disease and reduce the risk of it spreading.

  • LHRH Agonist

    is a type of hormone therapy used to lower the levels of male hormones in the body, which can help slow down or stop the growth of prostate cancer cells. It is part of the standard treatment in this trial, combined with radiotherapy, to manage hormone-sensitive prostate cancer.

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 high-risk recurrent prostate cancer, particularly in patients who have previously undergone radical prostatectomy. The medication works by blocking the action of androgens, which are male hormones that can promote the growth of prostate cancer cells. Apalutamide is classified as an androgen receptor inhibitor.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, or bone pain. The cancer can spread to other parts of the body, such as bones and lymph nodes. The progression is typically monitored through imaging tests and blood markers. Treatment aims to manage the disease and prevent further spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505852-23-00Protocol code56021927PCR3015Estimated enrolment480 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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