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Study on Darolutamide and Radiation Therapy for Patients with Castration-Resistant Prostate Cancer and Oligometastases

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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 type of prostate cancer known as castration-resistant prostate cancer (CRPC) with a small number of metastases, which are areas where the cancer has spread. The study will explore the effectiveness of a treatment called darolutamide, which is a medication taken as a film-coated tablet. The trial will also investigate whether combining darolutamide with a type of precise radiation treatment called stereotactic body radiation therapy is more effective than using darolutamide alone. The goal is to see if this combination can help patients live longer without the cancer getting worse, as seen on imaging tests.

Participants in the study will receive either darolutamide alone or darolutamide combined with radiation therapy. The study will monitor how the cancer responds to these treatments over time. Other medications that may be used in the study include degarelix, triptorelin, leuprorelin acetate, and goserelin, which are different types of hormone therapies given by injection. These medications help to lower testosterone levels, which can slow the growth of prostate cancer.

The trial aims to determine if the combination of darolutamide and radiation therapy is better at preventing the cancer from progressing compared to darolutamide alone. The study will also look at the safety and side effects of the treatments, as well as their impact on overall survival, quality of life, and other health outcomes. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the effectiveness of the treatments.

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 reviewing medical history and performing necessary tests to ensure all criteria are met.

  2. Step 2

    Medication administration

    The patient begins treatment with darolutamide, administered orally. The specific dosage and frequency are determined by the study protocol.

    Additional medications may include degarelix, triptorelin, leuprorelin acetate, and goserelin, which are administered via subcutaneous or intramuscular injections as specified in the study protocol.

  3. Step 3

    Radiation therapy

    For patients receiving combination treatment, stereotactic body radiation therapy is administered. This therapy targets specific metastatic sites identified through imaging.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring is conducted to assess the patient's response to treatment. This includes imaging studies and laboratory tests to evaluate disease progression and treatment effects.

  5. Step 5

    Follow-up visits

    Scheduled follow-up visits are required to monitor health status and manage any side effects. These visits include physical examinations and discussions about any symptoms or concerns.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is performed to assess the overall effectiveness of the therapy and any long-term effects.

Who can join the trial?

16 criteria

  • The patient must have signed a written informed consent before any trial-specific procedures. If the patient cannot physically sign, a trusted person can confirm the patient's consent in writing.
  • The patient must have **adequate liver function**, which means bilirubin levels less than 3 mg/dL and albumin levels greater than 2.5 g/dL.
  • The patient's **blood pressure** should be less than 160/100 mmHg. If the patient has high blood pressure, it must be controlled and meet all other criteria.
  • The patient must have **adequate kidney function**, with a creatinine clearance greater than 30 mL/min. This is a measure of how well the kidneys are working.
  • The patient should have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • The patient must be willing to use **contraception** during the trial and for at least one week after stopping the medication darolutamide.
  • The patient must be part of the social security system or an equivalent system according to local regulations for clinical trials.
  • The patient must be willing and able to follow the trial protocol, including attending treatment sessions, scheduled visits, and follow-up examinations.
  • The patient must be at least 18 years old.
  • The patient must have a confirmed diagnosis of **adenocarcinoma prostate cancer** without small cell or pure endocrine features.
  • The patient must have a history of local treatment for prostate cancer, such as surgery or radiotherapy, with the intent to cure.
  • The patient must have **castration-resistant prostate cancer**, which means the cancer continues to grow even when testosterone levels are low.
  • The patient must have 1 to 5 **metastatic sites** detected on a special type of scan called PET, using choline, fluciclovine, or PSMA as a tracer. Metastatic sites are areas where cancer has spread.
  • All metastatic sites must be treatable with **stereotactic radiation therapy**, a precise form of radiation treatment.
  • The patient must have normal **blood function**, with specific levels of neutrophils, platelets, and hemoglobin.
  • The patient must have normal **liver function**, with specific levels of bilirubin, ASAT, and ALAT, unless they have a condition called Gilbert's syndrome.

Who cannot join the trial?

5 criteria

  • Patients who do not have castrate-resistant prostate cancer with oligometastases. This means the cancer has not spread to a few other parts of the body.
  • Patients who have more than 5 oligometastases. Oligometastases refer to a small number of cancer spread areas.
  • Patients who are not male, as the study is only for male participants.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Darolutamide

    is a medication used in this trial to treat prostate cancer that has become resistant to traditional hormone therapy. It works by blocking the effects of male hormones that can promote the growth of cancer cells. The trial is investigating whether using darolutamide alone or in combination with another therapy can help control the spread of cancer.

  • Stereotactic Body Radiation Therapy (SBRT)

    is a type of radiation treatment that precisely targets cancer cells in the body. It delivers high doses of radiation to the cancer while minimizing damage to surrounding healthy tissue. In this trial, SBRT is being used in combination with darolutamide to see if this approach is more effective in preventing the cancer from progressing compared to using darolutamide alone.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating castrate-resistant prostate cancer with oligometastases. The main therapeutic indication is for patients with prostate cancer that continues to progress despite hormone therapy. At the molecular level, darolutamide works by blocking androgen receptors, which are proteins that can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor.

Investigated diseases

Castrate-resistant prostate cancer with oligometastases – This form of prostate cancer continues to progress despite treatments that lower testosterone, a hormone that typically fuels prostate cancer growth. It is characterized by the presence of a limited number of metastases, typically between one to five, which can be detected using advanced imaging techniques like PSMA or choline/fluciclovine PET scans. The disease may initially present with localized symptoms, but as it progresses, it can spread to other parts of the body, often affecting bones and lymph nodes. The progression of the disease is monitored through imaging and changes in prostate-specific antigen (PSA) levels. The condition is considered challenging due to its resistance to conventional hormone therapies, necessitating alternative treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507482-26-00Protocol codeUC-GTG-2306Estimated enrolment287 patientsSponsorUnicancer

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