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Study of Apalutamide and Androgen Deprivation Therapy for Patients with High-Risk 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 the effects of a treatment for prostate cancer, specifically in patients with high-risk localized or locally advanced forms of the disease. The treatment being tested includes a combination of androgen deprivation therapy (ADT) and a medication called apalutamide, which is also known by its code name JNJ-56021927. The purpose of the study is to determine if this combination treatment, given before and after surgery to remove the prostate, can improve outcomes compared to a placebo plus ADT.

Participants in the study will receive the treatment over a period of up to 12 months. The study involves taking apalutamide in the form of film-coated tablets, which are taken orally. Additionally, ADT may involve the use of other hormone-related agents administered through subcutaneous (under the skin) injections. The study will also use imaging techniques, such as PSMA PET scans, to monitor the progress of the treatment and assess its effectiveness in preventing the spread of cancer.

The trial aims to provide valuable information on whether the combination of apalutamide and ADT can lead to better outcomes for patients undergoing surgery for prostate cancer. This includes looking at the rate of complete response to the treatment and the time it takes for the cancer to spread to other parts of the body. The results of this study could help improve treatment strategies for patients with high-risk 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies may be performed to ensure the patient meets the study criteria.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving apalutamide plus androgen deprivation therapy (ADT), and the other receiving a placebo plus ADT.

    This process is double-blind, meaning neither the patient nor the study team knows which group the patient is in.

  3. Step 3

    Treatment phase

    Patients in the treatment group receive apalutamide in the form of film-coated tablets, taken orally.

    The dosage and frequency of apalutamide are determined by the study protocol and are administered alongside ADT.

    The treatment phase occurs both before and after the surgical procedure known as radical prostatectomy (RP) with pelvic lymph node dissection (pLND).

  4. Step 4

    Surgical procedure

    Eligible patients undergo a surgical procedure called radical prostatectomy (RP) with pelvic lymph node dissection (pLND).

    This surgery is part of the treatment plan for patients with high-risk localized or locally advanced prostate cancer.

  5. Step 5

    Follow-up and monitoring

    After the treatment phase, patients are monitored regularly to assess the effectiveness of the treatment.

    Follow-up includes imaging studies and laboratory tests to evaluate the patient's response to the treatment and to check for any side effects.

  6. Step 6

    Study completion

    The study is expected to conclude by July 2024.

    Final assessments are conducted to determine the primary outcomes, including the pathological complete response (pCR) rate and metastasis-free survival (MFS).

Who can join the trial?

13 criteria

  • Must be at least 18 years old.
  • Must sign an informed consent form, which means you understand the study and agree to participate.
  • Must have a confirmed diagnosis of prostate cancer, specifically a type called adenocarcinoma.
  • Must have high-risk prostate cancer, which is determined by specific scores and tests related to the cancer's aggressiveness.
  • Must be a candidate for a surgery called RP with pLND, as decided by the study doctor.
  • Must have a good general health status, measured by a score called the Eastern Cooperative Oncology Group (ECOG) Performance Status, which should be 0 or 1. This score indicates how well you can perform daily activities.
  • Must have normal organ function, which is checked by specific blood tests. These include:
    • AST and ALT, which are liver enzymes, and total bilirubin should be within normal limits.
    • Serum creatinine, a kidney function marker, should be less than 1.8 mg/dL.
    • Platelet count should be at least 75,000 per microliter without recent transfusions or growth factors.
    • Hemoglobin level should be at least 12.0 g/dL without recent transfusions or growth factors.
    • Must be able to receive a treatment called ADT for at least 13 months, based on heart health and the study doctor's assessment.
    • Must be able to swallow the study drug tablets whole.
    • Must follow local regulations regarding contraceptive use if applicable.

Who cannot join the trial?

3 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who do not have high-risk localized or locally advanced prostate cancer cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who might not be able to make decisions for themselves.
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Investigated drugs

  • Apalutamide

    is a medication used in this trial to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, it is being tested to see if it can improve outcomes for patients with high-risk localized or locally advanced prostate cancer when used before and after surgery.

  • ADT (Androgen Deprivation Therapy)

    is a treatment that reduces the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so lowering their levels can slow down or stop the growth of the cancer. In this trial, ADT is used in combination with apalutamide to see if it enhances the treatment's effectiveness.

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 localized or locally advanced prostate cancer. The main therapeutic indication for apalutamide is prostate cancer, particularly in patients who are candidates for radical prostatectomy. At the molecular level, apalutamide works by blocking the action of androgens, which are male hormones that can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor, which helps to slow down or stop the growth of cancer cells by interfering with their ability to use androgens.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It is often categorized by its risk level and stage, such as high-risk localized or locally advanced, indicating that the cancer is confined to the prostate or nearby but has a higher chance of spreading. The progression of prostate cancer can vary, with some forms growing slowly and others more aggressively. Symptoms may not appear until the cancer is advanced and can include difficulty urinating, blood in urine, or pelvic discomfort. The disease is typically monitored through imaging and other tests to assess its spread and impact.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506153-38-00Protocol code56021927PCR3011Estimated enrolment1 992 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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