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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Hopitaux Universitaires Pitie Salpetriere Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitair Ziekenhuis Gent Gent Belgium
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
MBAL Trakia EOOD Stara Zagora Bulgaria
Hospital Clinic De Barcelona Barcelona Spain
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Dobrich AD Dobrich Bulgaria
Centre Hospitalier Universitaire De Nantes Nantes France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Vedwfdxmq ilyhmoxl Vbieltal uhceryereawr lgstkmpzx Srdtjmkz kjqpcep flxwrxiq Nyujllmgzjfi voogz ciswjod Vilnius Lithuania
Ierklb Idlafnql Fzdsizqujxtyb Onhbgmwmdsr Rome Italy
Ccipxj Hxgzahonfpf Rmqnmimh Dwowqzhompriob Angers France
Els Pmzisodqv Sho z oejd Piaseczno Poland
Pvst Tkhhj Heblknmn Ulqvveiqrphf Sabadell Spain
Hkkmerat Vvnn ddwdzkmy Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.08.2024
Bulgaria Bulgaria
Not recruiting
21.08.2024
France France
Not recruiting
21.08.2024
Italy Italy
Not recruiting
21.08.2024
Lithuania Lithuania
Not recruiting
21.08.2024
Poland Poland
Not recruiting
21.08.2024
Spain Spain
Not recruiting
21.08.2024

Trial locations

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.

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 ID:
2024-511038-11-00
Protocol code:
Debio 4228-201
Trial Phase:
Therapeutic exploratory (Phase II)

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