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Study on Darolutamide for Patients with High-Risk Localized or Locally Advanced 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 a type of prostate cancer known as high-risk localized or locally advanced prostate adenocarcinoma. The treatment being investigated is a medication called Darolutamide, which is also known by its code names ODM-201 and BAY 1841788. Darolutamide is an androgen receptor inhibitor, which means it works by blocking the effects of male hormones that can promote the growth of prostate cancer cells.

The purpose of the study is to assess the effectiveness of a genomic biomarker called PCAI ImmunoScore in predicting the response of prostate cancer to treatment with Darolutamide before surgery to remove the prostate, known as a radical prostatectomy. The study will observe how well the cancer responds to the treatment by looking at the amount of cancer left after treatment, referred to as minimal residual disease (MRD). Participants will take Darolutamide for a period of 90 to 120 days before undergoing surgery.

Throughout the study, researchers will also examine various factors such as changes in tumor size, blood levels of a protein called PSA (prostate-specific antigen), and any side effects related to hormone levels. The study aims to provide insights into how well the PCAI ImmunoScore can predict treatment outcomes and help tailor future treatments for prostate cancer patients. Participants will be monitored for changes in their condition and any side effects during and after the treatment period.

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

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your willingness to participate.

    You must be at least 18 years old and have a recent prostate MRI, not older than 3 months, to confirm eligibility.

  2. Step 2

    Initial assessments

    A biopsy will confirm the presence of high-risk prostate cancer. This is defined by specific scores from your MRI and biopsy results.

    Your overall health will be assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status, which should be 0 or 1, indicating you are fully active or have some symptoms but do not require bed rest.

  3. Step 3

    Medication administration

    You will begin taking darolutamide, which is provided as NUBEQA 300 mg film-coated tablets. This medication is taken orally.

    The dosage is 300 mg, and you will take it as directed by the study team for a period of 90 to 120 days.

  4. Step 4

    Monitoring and assessments

    Throughout the treatment period, your response to the medication will be monitored. This includes regular assessments of your prostate cancer status using MRI and other tests.

    Blood tests will be conducted to measure prostate-specific antigen (PSA) levels and other relevant markers.

  5. Step 5

    Surgical procedure

    After completing the medication course, you will undergo a surgical procedure known as radical prostatectomy, which involves the removal of the prostate gland.

    The surgery aims to remove any remaining cancerous tissue.

  6. Step 6

    Post-surgical follow-up

    Following surgery, you will have follow-up visits to assess recovery and any side effects from the treatment.

    Your functional outcomes, such as erectile function and urinary continence, will be evaluated through questionnaires.

Who can join the trial?

9 criteria

  • Patients must be 18 years of age or older.
  • A clinical Prostate MRI (Magnetic Resonance Imaging) must have been done within the last 3 months at the time of screening.
  • Must have a biopsy-confirmed high-risk prostate cancer, defined as a global ISUP-score (a grading system for prostate cancer) of 4 or higher with any MRI PIRADS score (a scoring system for prostate imaging) or a global ISUP-score of 3 with an MRI PIRADS score of 5.
  • Must be a candidate for radical prostatectomy (surgery to remove the prostate gland).
  • Must have an ECOG Performance Status score of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must be able to receive Darolutamide (a medication used to treat prostate cancer) for 90-120 days.
  • Must have signed an informed consent form, indicating understanding and agreement to participate in the study.
  • If sexually active, must be willing to use a condom from the screening visit up to 1 week after the last dose of Darolutamide, unless the participant is sterile or the partner is postmenopausal, permanently sterilized, or using a highly effective method of contraception.
  • Must be able to understand and comply with planned study procedures and be willing to be available for all study-required procedures, visits, and calls for the duration of the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have high-risk localized or locally advanced prostate adenocarcinoma cannot participate. This means the study is only for those with a specific type of prostate cancer that is either confined to the prostate or has spread to nearby areas but is considered high-risk.
  • Only male patients can participate. Female patients are not eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Darolutamide is a medication used in this clinical trial to treat prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down or stop the growth of cancer cells in the prostate. In this study, Darolutamide is given to patients before they undergo surgery to remove the prostate, with the aim of reducing the size of the cancer and making the surgery more effective. The trial is also looking at how well a specific biomarker can predict the success of this treatment in reducing the cancer to minimal levels.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating high-risk localized or locally advanced prostate cancer. The main therapeutic use of Darolutamide is to help manage prostate cancer by blocking the effects of male hormones that can promote the growth of cancer cells. At the molecular level, Darolutamide works by binding to androgen receptors, preventing these hormones from activating the receptors and thus inhibiting cancer cell growth. It is classified as an androgen receptor inhibitor in pharmacology.

Investigated diseases

Prostate Adenocarcinoma – Prostate adenocarcinoma is a type of cancer that begins in the gland cells of the prostate, which is a small gland in men that produces seminal fluid. The disease often progresses slowly and may not show symptoms in its early stages. As it advances, it can cause urinary difficulties, pelvic discomfort, and erectile dysfunction. The cancer can spread to nearby tissues and organs, such as the bladder or rectum, and may also metastasize to bones and lymph nodes. The progression of the disease is often monitored through prostate-specific antigen (PSA) levels in the blood. Advanced stages may lead to more significant health issues, affecting overall quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520639-17-00Protocol codePARIS-BIO 1.0Estimated enrolment100 patientsSponsorKarolinska University Hospital

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