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Study Comparing Darolutamide and Androgen Deprivation Therapy to Placebo and Androgen Deprivation Therapy in Men with High-Risk Prostate Cancer Recurrence

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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 biochemically recurrent prostate cancer. This condition occurs when there is a rise in the blood levels of a specific protein called PSA, which can indicate a high risk of prostate cancer returning after initial treatment. The study will explore the effectiveness of a treatment called darolutamide, which is used in combination with another therapy known as androgen deprivation therapy (ADT). The trial will compare this combination to a placebo combined with ADT to see if it can improve outcomes for patients.

The purpose of the study is to determine if the combination of darolutamide and ADT, given over a period of 24 months, can improve a specific measure of cancer progression when compared to a placebo and ADT. During the study, participants will receive either the active treatment or a placebo, and their progress will be monitored using a special imaging technique called PSMA PET/CT. This imaging method helps to identify cancerous lesions in the body. The study will last for a total of 24 months, and participants will undergo regular assessments to track their response to the treatment.

In addition to darolutamide, the study will also use imaging agents such as Gallium (68Ga) PSMA-11 (gozetotide) and Piflufolastat (18F) to assist in the PSMA PET/CT scans. These agents help to highlight cancer cells during the imaging process, making it easier to assess the effectiveness of the treatment. The trial aims to provide valuable insights into whether this combination therapy can offer better outcomes for patients with high-risk prostate cancer recurrence.

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 screening

    Upon joining the study, you will undergo an initial screening to ensure eligibility. This includes a review of your medical history and a series of tests to check your blood levels and overall health.

    You will need to have a PSMA PET/CT scan to identify any prostate cancer lesions. This scan uses a special imaging technique to provide detailed pictures of your prostate.

  2. Step 2

    Randomization

    After passing the screening, you will be randomly assigned to one of two groups. One group will receive the study medication darolutamide along with androgen deprivation therapy (ADT), while the other group will receive a placebo with ADT.

    This process is called randomization and ensures that the study results are unbiased.

  3. Step 3

    Treatment phase

    During the treatment phase, you will take the assigned medication for a duration of 24 months. If you are in the darolutamide group, you will take it in the form of a film-coated tablet by mouth.

    You will also continue with ADT, which is a standard treatment for prostate cancer. The frequency and dosage of the medications will be explained to you by the study team.

  4. Step 4

    Regular monitoring

    Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This includes blood tests, imaging scans, and assessments of your prostate-specific antigen (PSA) levels.

    These visits are important to track your progress and ensure your safety during the trial.

  5. Step 5

    End of treatment

    At the end of the 24-month treatment period, you will have a final evaluation to assess the outcomes of the study treatment.

    This will include a comprehensive review of your health status and any changes in your condition.

  6. Step 6

    Follow-up

    After completing the treatment phase, you will enter a follow-up period where your health will continue to be monitored for any long-term effects or changes.

    The study team will provide guidance on the frequency and nature of these follow-up visits.

Who can join the trial?

18 criteria

  • Must be able to give signed informed consent, which means you understand the study and agree to follow its rules.
  • Blood tests must show:
    • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) levels no more than 1.5 times the normal limit. These are liver enzymes.
    • Total bilirubin (TBL) no more than 1.5 times the normal limit, unless you have Gilbert's disease, a mild liver condition.
    • Estimated glomerular filtration rate (eGFR) greater than 40 ml/min/1.73 m², which measures kidney function.
    • If sexually active, must agree to use contraception during the study and for at least 1 week after the last dose, and not donate sperm during this time.
    • Must be a male aged 18 years or older.
    • Must have a confirmed diagnosis of prostate cancer through a tissue sample.
    • Prostate cancer must have been initially treated with:
      • Radical prostatectomy (surgery to remove the prostate) followed by adjuvant radiotherapy (ART) or salvage radiotherapy (SRT).
      • Radical prostatectomy alone if unfit for or refused ART or SRT.
      • Primary radiotherapy (RT) alone.
      • Must have high-risk biochemical recurrence (BCR), which means:
        • Prostate-specific antigen (PSA) doubling time less than 12 months and PSA level of at least 0.2 ng/mL after ART or SRT post-surgery, or after surgery if unfit for ART or SRT.
        • PSA level of at least 2 ng/mL above the lowest point after primary RT only.
        • Must undergo a PSMA PET/CT scan within 42 days before starting the study to identify at least one positive lesion of prostate cancer. This scan uses special tracers to detect cancer cells.
        • Serum testosterone level must be at least 150 ng/dL (5.2 nmol/L). Testosterone is a male hormone.
        • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest.
        • Blood counts at screening must show:
          • Hemoglobin level of at least 9.0 g/dL, without a blood transfusion in the last 7 days. Hemoglobin is a protein in red blood cells.
          • Absolute neutrophil count (ANC) of at least 1.5 x 10⁹/L, without growth factor treatment in the last 4 weeks. Neutrophils are a type of white blood cell.
          • Platelet count of at least 100 x 10⁹/L. Platelets help with blood clotting.

Who cannot join the trial?

3 criteria

  • Patients who do not have biochemically recurrent prostate cancer cannot participate. This means the cancer has returned, as shown by specific blood tests, but may not be visible on scans.
  • Only male patients are eligible to participate in this study.
  • Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Darolutamide

    is a medication used in this clinical trial to help treat prostate cancer. It works by blocking the effects of male hormones, like testosterone, which can help slow down or stop the growth of cancer cells. In this study, darolutamide is combined with another therapy to see if it can improve the outcomes for patients with a specific type of prostate cancer.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones in the body. These hormones can promote the growth of prostate cancer cells, so lowering their levels can help control the cancer. ADT is often used in combination with other treatments to enhance its effectiveness in managing prostate cancer.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating biochemically recurrent prostate cancer. It is used in combination with androgen deprivation therapy (ADT) to potentially improve outcomes for patients with high-risk prostate cancer. Darolutamide works by blocking the action of male hormones, such as testosterone, which can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor, which means it helps to prevent cancer cells from receiving the signals they need to grow.

Investigated diseases

Biochemically recurrent prostate cancer – This condition occurs when prostate cancer returns, as indicated by a rise in prostate-specific antigen (PSA) levels, after initial treatment such as surgery or radiation. It is characterized by an increase in PSA without any visible signs of cancer on imaging tests. The progression of this disease can vary, with some patients experiencing a slow increase in PSA levels over time, while others may have a more rapid rise. The disease may remain confined to the prostate area or eventually spread to other parts of the body. Monitoring PSA levels is crucial in understanding the progression of this condition. The disease's course can influence decisions regarding further treatment options.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501343-33-00Protocol code21492Estimated enrolment987 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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