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Can a new pill outsmart resistant prostate cancer?

NCT ID NCT03436485

Disease control Sponsor: Orion Corporation, Orion Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial is testing an experimental oral drug called ODM-208 in men with metastatic castration-resistant prostate cancer, a type of prostate cancer that has spread and no longer responds to standard hormone therapy. The main goal is to find the highest safe dose and to assess the drug's safety and how the body processes it. Participants take ODM-208 daily along with other medications to manage side effects. The study aims to determine if this drug can be a viable treatment option for this challenging condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ODM-208, an oral drug, taken daily with glucocorticoid and fludrocortisone
What this could lead to
If successful, this could lead to a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapies.
What could go wrong
This is an early-phase trial, so the drug may not be effective or may cause significant side effects. The results are preliminary and need further validation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

204 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: * Written informed consent (IC) obtained. * Male aged ≥ 18 years. * Histologically confirmed adenocarcinoma of the prostate. * Castration resistant prostate cancer with serum testosterone \< 50 ng/dl. * Metastatic disease. * Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy. * Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide). * ECOG performance status 0-1. * Adequate marrow, liver and kidney function. * Able to swallow study treatment. * Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC. Main Exclusion Criteria: * History of pituitary or adrenal dysfunction. * Known brain metastases or active leptomeningeal disease. * Active infection or other medical condition that would make corticosteroid contraindicated. * Poorly controlled diabetes. * Hypotension or uncontrolled hypertension. * Clinically significantly abnormal serum potassium or sodium level. * Active or unstable cardio/cerebro-vascular disease including thromboembolic events. * Prolonged QTcF interval.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer metastatic

Contacts and locations

Locations

  • Centre Léon Bérard

    Lyon, France

  • Charing Cross Hospital

    London, United Kingdom

  • Helsinki University Central Hospital

    Helsinki, Finland

  • Hopital Foch

    Suresnes, 92150, France

  • Institut Gustave Roussy

    Villejuif, France

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, France

  • Institute Bergonié

    Bordeaux, France

  • Institute Paoli-Calmettes

    Marseille, France

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114, United States

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal Preston Hospital

    Preston, PR2 9HT, United Kingdom

  • Tampere University Hospital

    Tampere, Finland

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The Rutherford Cancer Centre, North East

    Bedlington, United Kingdom

  • The Rutherford Cancer Centre, North West

    Liverpool, United Kingdom

  • University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative

    Buffalo, New York, 14203, United States

  • University of Maryland Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

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