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Study of Darolutamide and Testosterone for Patients with Advanced Prostate Cancer Resistant to Standard Hormone Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on metastatic castration-resistant prostate cancer, which is an advanced form of prostate cancer that has spread beyond the prostate and no longer responds to treatments that lower testosterone levels. The research examines the combination of two treatments: darolutamide (a medication that blocks the effects of male hormones) and bipolar androgen therapy (BAT), which involves alternating between high and low testosterone levels. Both treatments will be given along with androgen deprivation therapy (ADT), which is a standard treatment that reduces testosterone production.

The purpose of this study is to determine if the combination of darolutamide with bipolar androgen therapy improves how long patients live without their cancer progressing and their quality of life compared to the current standard treatment. Participants will be randomly assigned to receive either the experimental treatment combination or the standard care, while continuing their androgen deprivation therapy throughout the study.

Clinical trial information for patient recruitment must be carefully reviewed by ethics committees and regulatory bodies to ensure it's accurate, balanced, and not misleading. Creating such content outside official channels could potentially:

  1. Provide misleading medical information
  2. Circumvent regulatory oversight designed to protect patients
  3. Be used in ways that don't align with proper informed consent processes

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The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment in the DaroBAT Trial

    After completing the informed consent process, you'll be enrolled in the DaroBAT clinical trial for metastatic castration-resistant prostate cancer (cancer that has spread beyond the prostate and no longer responds to hormone therapy that lowers testosterone).

    You will be randomly assigned to either the experimental treatment group or the standard care group. Both groups will continue to receive androgen deprivation therapy (ADT), which is treatment that keeps testosterone levels very low.

  2. Step 2

    Treatment Pathway

    If assigned to the experimental group, you will receive Darolutamide (a medication that blocks the effects of testosterone) along with Bipolar Androgen Therapy (BAT), which involves testosterone treatment given in cycles.

    If assigned to the standard care group, you will continue with the standard treatment approach for this type of cancer while maintaining ADT.

  3. Step 3

    Medication Administration

    For those in the experimental group, Darolutamide will be administered as film-coated tablets according to the dosage schedule provided by your doctor.

    The Bipolar Androgen Therapy will include Testogel, a testosterone gel applied to the skin (transdermal) containing 16.2 mg/g of testosterone.

    Throughout the trial, your testosterone levels will be monitored to ensure they remain at appropriate levels for the study protocol.

  4. Step 4

    Monitoring and Testing

    Regular PSA blood tests will be conducted to monitor your prostate-specific antigen levels, which help track how your cancer is responding to treatment.

    You will undergo imaging scans (CT/MRI, bone scan, or PSMA-PET-CT) at scheduled intervals to check if the cancer is growing, shrinking, or remaining stable.

    Regular blood tests will be performed to monitor your liver function, kidney function, and blood cell counts throughout the trial.

  5. Step 5

    Quality of Life Assessment

    You will complete quality of life questionnaires using the FACIT-F scale, which helps measure fatigue and other aspects of your wellbeing during treatment.

    These assessments will continue until disease progression and help researchers understand how the treatments affect your daily life and overall health.

  6. Step 6

    Side Effect Monitoring

    Throughout the trial, you will be monitored for any side effects or adverse reactions to the medications.

    It's important to report any new symptoms or changes in your health to the study team, even if they seem unrelated to the study.

  7. Step 7

    Follow-up Period

    You will continue treatment until disease progression (when the cancer starts growing again despite treatment), unacceptable side effects, or until the study ends in December 2027.

    After treatment ends, you will enter a follow-up period where your health will continue to be monitored, with particular attention to overall survival.

  8. Step 8

    Safety Considerations

    Throughout the trial, you must use effective birth control methods if sexually active. Male participants must use condoms and refrain from sperm donation during treatment and for 6 months after treatment ends.

    Female partners of childbearing potential must also use highly effective birth control methods during this period.

Who can join the trial?

16 criteria

  • You must be a man aged 18 years or older
  • You must have confirmed prostate adenocarcinoma (a type of prostate cancer)
  • You must have metastatic castration-resistant prostate cancer (cancer that has spread beyond the prostate and continues to grow despite treatments that lower testosterone)
  • You must have a PSA level of 1.0 ng/mL or higher at screening (PSA is a prostate-specific antigen, a blood test that measures a protein produced by the prostate)
  • You must have been receiving continuous hormone therapy (either surgical removal of testicles or medications that lower testosterone) combined with an ARI medication (Apalutamide, Darolutamide, or Enzalutamide)
  • You must have a documented castrate level of testosterone (less than 50 ng/dl, showing your testosterone is being effectively suppressed)
  • Your cancer must have spread (metastasized) as confirmed by imaging tests (CT/MRI, bone scan, or PSMA-PET-CT)
  • Your disease must have progressed while on Apalutamide, Darolutamide or Enzalutamide, shown by either:
    • Rising PSA levels (at least 25% increase in two consecutive measurements at least one week apart), or
    • Growth of tumors on imaging scans
    • You must have an ECOG Performance Status of 2 or less (this measures your ability to perform daily activities and self-care)
    • Your last radiation treatment must have been at least 4 weeks ago
    • You must have acceptable liver function tests
    • You must have acceptable kidney function
    • You must have acceptable blood counts
    • If sexually active, you must agree to use condoms and your female partners of childbearing potential must use effective birth control during treatment and for 6 months after
    • You must be able to understand and willing to sign an informed consent form

Who cannot join the trial?

11 criteria

  • You have cancer that has spread outside the prostate to other parts of the body and does not respond to hormone therapy that lowers testosterone (a male hormone).
  • You have an allergy to the study drugs.
  • You have serious heart problems such as unstable chest pain, heart failure, or recent heart attack.
  • You have a history of seizures or conditions that might cause seizures.
  • You have severe liver problems.
  • You have severe kidney problems.
  • You are currently taking certain medications that might interact with the study drugs.
  • You have participated in another clinical trial within the last 30 days.
  • You have had chemotherapy or other anti-cancer treatments recently.
  • You have other serious medical conditions that might interfere with the study.
  • You are unable to follow the study procedures or attend required visits.
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Investigated drugs

  • Darolutamide

    is a medication used to treat prostate cancer. It works by blocking the effects of male hormones (like testosterone) that can stimulate cancer growth. It is typically taken as a pill.

  • Bipolar Androgen Therapy (BAT)

    is a treatment approach that involves giving high doses of testosterone followed by periods of very low testosterone levels. This cycling between high and low hormone levels can sometimes help control prostate cancer growth.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones (androgens) in the body. It's commonly used for prostate cancer because these hormones can stimulate cancer growth. ADT can be given as injections, implants under the skin, or pills.

What is already known about the treatment

  • Darolutamide

    An oral androgen receptor inhibitor used to treat metastatic castration-resistant prostate cancer. It works by blocking the effects of androgens (male hormones) at the molecular level, preventing them from binding to androgen receptors in cancer cells and thereby slowing tumor growth. Darolutamide belongs to the class of medications called androgen receptor antagonists and has been approved for clinical use based on studies showing improved survival outcomes. It's typically administered as tablets taken daily alongside ongoing hormone therapy (ADT), with the advantage of having fewer side effects related to brain penetration compared to similar medications.

  • Bipolar Androgen Therapy (BAT)

    An innovative treatment approach for metastatic castration-resistant prostate cancer that involves alternating between very high and very low testosterone levels. Unlike traditional therapies that aim to keep testosterone suppressed, BAT administers high doses of testosterone (typically via injection) at scheduled intervals while maintaining androgen deprivation therapy. This treatment works by disrupting cancer cell growth through rapid changes in hormone levels, potentially resensitizing tumors to other treatments. BAT represents an emerging strategy still being evaluated in clinical trials, showing promising results for patients who have developed resistance to standard hormonal therapies.

Investigated diseases

Metastatic castration-resistant prostate cancer – A form of prostate cancer that has spread beyond the prostate to other parts of the body (metastasized) and continues to grow despite medical or surgical treatments that lower testosterone levels. In this condition, cancer cells have developed ways to survive and multiply even with very low levels of testosterone in the body. The disease typically evolves from hormone-sensitive prostate cancer after hormone therapy stops being effective. As it progresses, patients may experience increased prostate-specific antigen (PSA) levels, new bone or soft tissue lesions, and sometimes pain or other symptoms related to the spread of cancer. Metastatic castration-resistant prostate cancer represents an advanced stage of prostate cancer with distinct treatment challenges.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521051-23-00Protocol codeUniMS22_0022Estimated enrolment60 patientsSponsorUniversitaet Muenster

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