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Study of Debio 4228 for Patients with Advanced or Metastatic Prostate Cancer

Fast replyInvestigationalNo placebo
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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 treatment for prostate cancer, specifically in cases where the cancer is locally advanced or has spread to other parts of the body, known as metastatic prostate cancer. The treatment being tested is called Debio 4228, which is a type of medication known as a gonadotropin-releasing hormone (GnRH) antagonist. This medication works by blocking certain hormones that can promote the growth of prostate cancer cells.

The purpose of the study is to explore how Debio 4228 behaves in the body and how it affects hormone levels over time. Participants in the study will receive the medication through an injection into the muscle. The study will last for several weeks, during which time participants will have regular check-ups to monitor their health and the effects of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of Debio 4228.

Throughout the study, researchers will pay close attention to how well the treatment works in lowering testosterone levels, which is a key goal in managing prostate cancer. They will also monitor any side effects or reactions at the injection site, as well as overall health indicators like blood tests and heart function. The study aims to gather important information that could help improve treatment options for people with advanced prostate cancer in the future.

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, eligibility is confirmed based on specific criteria such as age, health status, and medical history related to prostate cancer.

    The study involves participants with locally advanced or metastatic prostate cancer.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate baseline health conditions, including blood tests to measure testosterone levels and other relevant health indicators.

    Participants must have a testosterone level greater than 150 ng/dL at the screening visit.

  3. Step 3

    Treatment administration

    The treatment involves the administration of Debio 4228, a medication in the form of a powder and solvent for suspension, given through an intramuscular injection.

    The medication is a gonadotropin-releasing hormone antagonist, which helps manage hormone levels in prostate cancer.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for 12 weeks to assess the medication's effects on hormone levels, including testosterone and other related parameters.

    Regular follow-up visits are scheduled to evaluate the treatment's impact and any side effects.

  5. Step 5

    Evaluation of treatment effects

    The primary focus is on the medication's ability to maintain testosterone levels below specific thresholds, indicating effective treatment.

    Secondary evaluations include assessments of pain at the injection site, changes in prostate-specific antigen (PSA) levels, and overall health indicators.

  6. Step 6

    Completion of study participation

    Upon completion of the study period, a final assessment is conducted to gather comprehensive data on the treatment's effectiveness and any long-term effects.

    Participants' health status is reviewed, and any necessary follow-up care is discussed.

Who can join the trial?

8 criteria

  • Participant with a confirmed diagnosis of locally advanced or metastatic prostate cancer. This means the cancer has spread beyond the prostate gland.
  • Participant must be considered by the study doctor as a candidate for continuous ADT (Androgen Deprivation Therapy), which is a treatment to lower male hormones.
  • Participant must have a morning blood testosterone level greater than 150 ng/dL during the screening visit.
  • Participant must be at least 18 years old.
  • Participant must have an ECOG performance status of 0-2. This is a scale used to assess how well a person can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Participant must have a life expectancy of at least 6 months.
  • Participant must have adequate function of the bone marrow, liver, and kidneys at the screening visit. This means these organs are working well enough to participate in the study.
  • Other specific criteria defined by the study protocol may also apply.

Who cannot join the trial?

3 criteria

  • Patients who do not have locally advanced or metastatic prostate cancer cannot participate. This means the cancer must have spread beyond the prostate or is in an advanced stage.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This typically refers to groups who may have additional risks or need special protection in research.
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Investigated drugs

Debio 4228 is an extended-release formulation of a gonadotropin-releasing hormone antagonist. It is being studied for its effects in participants with locally advanced or metastatic prostate cancer. This medication works by blocking the action of certain hormones that stimulate the growth of prostate cancer cells, potentially slowing down or stopping the progression of the disease.

What is already known about the treatment

Debio 4228 – Debio 4228 is an extended-release formulation administered as an injection, designed to treat locally advanced or metastatic prostate cancer. It is currently in Phase 2 clinical trials, where researchers are studying its pharmacokinetics and pharmacodynamics. The medication works by acting as a gonadotropin-releasing hormone antagonist, which helps to lower testosterone levels, slowing the growth of prostate cancer cells. It falls under the pharmacological classification of hormone antagonists, specifically targeting hormone pathways involved in cancer progression.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Symptoms may include difficulty urinating, blood in urine, or pelvic discomfort. The disease is categorized into stages, with locally advanced indicating spread beyond the prostate but not to distant sites, and metastatic indicating spread to other body parts. Monitoring involves tracking changes in prostate-specific antigen (PSA) levels and other markers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511038-11-00Protocol codeDebio 4228-201Estimated enrolment83 patientsSponsorDebiopharm International SA

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