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Study of ODM-208 (opevesostat) safety and effectiveness in patients with metastatic castration-resistant prostate cancer

Verified siteRegistered drugNo placebo
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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 patients with metastatic castration-resistant prostate cancer, a condition where prostate cancer has spread to other parts of the body and continues to grow despite treatments that lower testosterone levels. The main treatment being tested is ODM-208 (also known as opevesostat), which is given as tablets in different strengths (5 mg, 25 mg, 50 mg, and 100 mg). Midazolam is also used in the study.

The purpose of this research is to evaluate how safe ODM-208 is for patients and to determine the most appropriate dose. The study also aims to assess how well the medication works in patients whose cancer has continued to grow after previous treatments with hormone therapy and chemotherapy. Additionally, researchers will examine how the drug interacts with certain proteins in the body.

During the study, participants will receive the study medication and undergo various medical examinations. These include blood tests, imaging scans (CT, MRI, bone scans), and regular check-ups to monitor their health status. Doctors will track changes in PSA (a protein that may indicate prostate cancer activity) and evaluate how the cancer responds to treatment. They will also collect blood and urine samples to study how the medication works in the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will undergo initial medical tests to confirm your eligibility for the study with metastatic castration-resistant prostate cancer

    Your testosterone levels must be below 50 ng/dl, and you must have documented disease progression

    Laboratory tests will check your blood counts, liver and kidney function

  2. Step 2

    Treatment initiation

    You will receive ODM-208 tablets to take by mouth

    The medication is available in different strengths: 5 mg, 25 mg, 50 mg, and 100 mg

    You must continue your current hormone therapy treatment during the study

  3. Step 3

    Regular monitoring

    Your health will be monitored through regular check-ups including:

    Blood pressure measurements

    Heart rate checks

    Body temperature readings

    Blood tests

    Urine tests

    Heart tests (ECG)

    Physical examinations

  4. Step 4

    Disease monitoring

    Your cancer will be monitored through:

    PSA blood tests (prostate-specific antigen)

    Imaging scans (CT or MRI) to check tumor status

    Bone scans

    Assessment of your daily activity level (ECOG score)

  5. Step 5

    Additional testing

    Blood samples will be collected to measure drug levels in your body

    Urine samples will be collected for analysis

    Hormone level measurements will be performed

    Some patients may have additional blood tests for research purposes

Who can join the trial?

11 criteria

  • Must be male and at least 18 years old
  • Must provide written informed consent to participate in the study
  • Must have received at least one type of hormone therapy targeting androgen receptors (like abiraterone, enzalutamide, darolutamide, or apalutamide) for at least 12 weeks
  • Must have documented disease progression shown by either: - Rising PSA levels (measured twice, at least 1 week apart) - Growth of tumors in soft tissues - Progression of bone disease
  • Must have adequate blood test results showing: - Sufficient red blood cells (hemoglobin) - Adequate white blood cells - Normal platelet count - Acceptable liver function - Normal kidney function
  • Must have a life expectancy of more than 3 months
  • Must be able to perform daily activities with minimal assistance (ECOG status 0-1)
  • Must have confirmed prostate cancer that has spread to other parts of the body (metastatic)
  • Must have very low testosterone levels (less than 50 ng/dl)
  • Must be continuing hormone therapy to suppress testosterone or have had surgery to remove testicles
  • Must have received at least one course of chemotherapy treatment or be unsuitable for chemotherapy

Who cannot join the trial?

13 criteria

  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions including uncontrolled high blood pressure or recent heart attack (within 6 months)
  • Significant liver problems or abnormal liver function tests
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except non-melanoma skin cancer)
  • Major surgery within 4 weeks before starting the study
  • Use of certain medications that can interact with the study drug (particularly those affecting CYP3A4, an important enzyme in the body)
  • History of severe allergic reactions to medications
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to swallow oral medications
  • Female patients (study is for male patients only)
  • Age under 18 years
  • Psychological, familial, sociological, or geographical conditions that could interfere with study participation
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Investigated drugs

ODM-208 is an investigational medication being studied for the treatment of metastatic castration-resistant prostate cancer. It works by targeting the androgen receptor pathway, which plays a crucial role in prostate cancer growth. This medication is being tested in patients whose cancer has continued to progress after previous treatments with hormone therapy and chemotherapy. The drug is particularly being studied in patients who may have mutations in the androgen receptor. The medication is being tested for how safe it is to use, how well patients tolerate it, and how effectively it fights cancer cells. It is also being studied to understand how it might interact with other medications through its effects on certain liver enzymes (specifically CYP3A4).

What is already known about the treatment

ODM-208 - An investigational drug being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC), administered orally in clinical trials. This experimental medication is being evaluated for its safety, tolerability, and effectiveness in patients who have progressed after previous treatments including AR-targeted therapy and taxane-based chemotherapy. ODM-208 is specifically being studied in patients with and without mutated androgen receptor ligand-binding domain, with particular attention to its interaction with CYP3A4 enzyme pathways. The drug represents a novel approach in the treatment of advanced prostate cancer, though it is still in clinical development and not yet approved for general medical use.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer - A progressive form of prostate cancer that continues to grow even when testosterone levels in the body are reduced to very low levels through medical or surgical treatment. In this condition, cancer cells have adapted to survive and multiply despite low testosterone levels. The disease is characterized by continuous growth of prostate cancer cells and their spread (metastasis) to other parts of the body, particularly bones and lymph nodes. The condition typically develops from earlier stages of prostate cancer that initially responded to hormone therapy. The cancer cells in this stage have developed mechanisms to grow despite conventional hormone treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517439-39-00Protocol code3124001Estimated enrolment171 patientsSponsorOrion Corporation

sourced from the EU Clinical Trials Register and site verification

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