Clinical trial • Phase II • Oncology|Other
DEGARELIX for Advanced prostate cancer
Phase II trial of DEGARELIX for Advanced prostate cancer. Randomised, open-label, none/not specified-controlled. 45 participants.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Advanced prostate cancer
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 19-04-2024
- First CTIS Authorization Date
- 17-07-2024
Trial design
Randomised, open-label, none/not specified-controlled Phase II trial across 27 sites in Spain, Belgium, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- None/Not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 45
- Trial Duration For Participant
- 169
Eligibility
Recruits 45 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be aged ≥18 years. Informed consent is required from participants; subject information and informed consent forms (Main ICF) and additional documents such as Pregnant Partner ICF, Data Privacy ICF and caregiver/patient ICFs are provided in multiple languages..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be aged ≥18 years. Informed consent is required from participants; subject information and informed consent forms (Main ICF) and additional documents such as Pregnant Partner ICF, Data Privacy ICF and caregiver/patient ICFs are provided in multiple languages.
Inclusion criteria
- {"criterion_text":"- Participant with histologically confirmed diagnosis of prostate cancer, with one of the following: a. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; b. Localized disease not suitable for local primary intervention with curative intent.\n- Participant judged by the Study Investigator to be candidate for continuous ADT\n- Baseline morning serum testosterone levels >150 ng/dL at screening visit\n- Age ≥18 years\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n- Life expectancy of at least 6 months\n- Adequate bone marrow, hepatic, and renal function at the screening visit\n- Other protocol and subprotocol defined criteria apply."}
Exclusion criteria
- {"criterion_text":"- Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and <6 months treatment-free interval before start of screening\n- Participant requires combination with androgen deprivation therapy with the exception of enzalutamide\n- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy\n- Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer\n- Abnormal cardiovascular function or diabetes\n- Use of exogenous testosterone within 6 months before the start of screening\n- Major surgery within 4 weeks before the start of screening\n- Cancer disease within the last two years except for prostate cancer and some skin cancers\n- Other protocol and subprotocol-defined criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Degarelix plasma PK profile and PK parameters over 12 weeks after Debio 4228 dosing, including but not limited to: - Maximum concentration (Cmax) - Area under the concentration-time curve over 12 weeks (AUC84d) - Concentration at 12 weeks (C84d) This will be derived for each treatment period.","definition_or_measurement_approach":"Plasma PK parameters of degarelix measured over 12 weeks post-dosing; includes calculation of Cmax, AUC over 12 weeks (AUC84d), and concentration at 12 weeks (C84d); derived for each treatment period."}
- {"endpoint_text":"- Testosterone serum concentration profile from Day 1 to Day 85 for all cohorts and from Day 85 to Day 169 in case of Cohort 3","definition_or_measurement_approach":"Serum testosterone concentrations measured at scheduled timepoints from Day 1 through Day 85 for all cohorts, and extended to Day 169 for Cohort 3."}
Secondary endpoints
- {"endpoint_text":"- Achievement and maintenance of testosterone castration (testosterone level <50 ng/dL and <20 ng/dL) from Day 29 to Day 85 for all cohorts","definition_or_measurement_approach":"Proportion of participants achieving and maintaining serum testosterone <50 ng/dL and <20 ng/dL from Day 29 to Day 85, assessed at scheduled timepoints."}
- {"endpoint_text":"- Maintenance of testosterone castration (testosterone level <50 ng/dL and <20 ng/dL) from Day 29 to Day 169 for Cohort 3","definition_or_measurement_approach":"Proportion of participants in Cohort 3 maintaining testosterone <50 ng/dL and <20 ng/dL from Day 29 to Day 169, assessed at scheduled timepoints."}
- {"endpoint_text":"- Time to castration (testosterone level <50 ng/dL and <20 ng/dL)","definition_or_measurement_approach":"Time from dosing to first occurrence of serum testosterone <50 ng/dL and <20 ng/dL."}
- {"endpoint_text":"- Investigator’s assessment (4-point rating scale) of erythema, swelling, and induration at the injection site immediately after Debio 4228 injection, 2 hours, and 24 hours (Day 2) after Debio 4228 injection","definition_or_measurement_approach":"Investigator-rated local tolerability using a 4-point scale at specified times post-injection (immediate, 2 hours, 24 hours)."}
- {"endpoint_text":"- Participants’ self-assessment of pain at the injection site immediately after Debio 4228 injection, 2 hours, and 24 hours (Day 2) after Debio 4228 injection using Numeric Pain Rating Scale (NPRS)","definition_or_measurement_approach":"Participant-reported numeric pain rating at immediate, 2-hour and 24-hour post-injection timepoints using the NPRS."}
- {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, adverse events of special interest (AESIs), death, and TEAEs leading to treatment delay, and/or discontinuation, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0;","definition_or_measurement_approach":"Safety endpoints captured as incidence and severity graded per NCI-CTCAE v5.0; includes TEAEs, related TEAEs, SAEs, AESIs, deaths, and TEAEs leading to delay/discontinuation."}
- {"endpoint_text":"- Percentage of change of PSA over time (per scheduled timepoint)","definition_or_measurement_approach":"Percent change from baseline in prostate-specific antigen (PSA) measured at scheduled timepoints."}
- {"endpoint_text":"- Time course of changes of LH and FSH (per scheduled timepoint)","definition_or_measurement_approach":"Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels measured over time at scheduled timepoints."}
- {"endpoint_text":"- Safety laboratory parameters and related severity based on NCI-CTCAE version 5.0","definition_or_measurement_approach":"Laboratory safety tests with severity graded per NCI-CTCAE v5.0."}
- {"endpoint_text":"- Changes from baseline in vital signs, weight, and electrocardiogram (ECG)","definition_or_measurement_approach":"Assessment of changes from baseline in vital signs, body weight, and ECG parameters at scheduled visits."}
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent is obtained from adult participants (age ≥18). Subject information and informed consent forms (Main ICF) are provided; additional ICFs include Pregnant Partner ICF, Data Privacy ICF, caregiver and patient ICFs. ICFs and participant-facing materials are available in multiple languages (English, Dutch, French, Spanish, Polish, Bulgarian, Lithuanian) as evidenced by document versions.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 41
Spain
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 13-08-2024
- Processing Time Days
- 61
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Radiation Oncology
- Principal Investigator Name
- Xavier Maldonado Pijoan
- Principal Investigator Email
- xavier.maldonado@vallhebron.cat
- Contact Person Name
- Xavier Maldonado Pijoan
- Contact Person Email
- xavier.maldonado@vallhebron.cat
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Urology
- Principal Investigator Name
- Pedro de Pablos Rodriguez
- Principal Investigator Email
- pdepablos@fivo.org
- Contact Person Name
- Pedro de Pablos Rodriguez
- Contact Person Email
- pdepablos@fivo.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Urology
- Principal Investigator Name
- Fiorella Lizzeth Roldán Chávez
- Principal Investigator Email
- flroldan@clinic.cat
- Contact Person Name
- Fiorella Lizzeth Roldán Chávez
- Contact Person Email
- flroldan@clinic.cat
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Urology
- Principal Investigator Name
- Juan Gomez Rivas
- Principal Investigator Email
- urolog.hcsc@salud.madrid.org
- Contact Person Name
- Juan Gomez Rivas
- Contact Person Email
- urolog.hcsc@salud.madrid.org
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Principal Investigator Name
- Enrique Gallardo Diaz
- Principal Investigator Email
- egallardo@tauli.cat
- Contact Person Name
- Enrique Gallardo Diaz
- Contact Person Email
- egallardo@tauli.cat
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 09-08-2024
- Processing Time Days
- 45
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Urology
- Principal Investigator Name
- Lieven Goeman
- Principal Investigator Email
- lieven.goeman@azdelta.be
- Contact Person Name
- Lieven Goeman
- Contact Person Email
- lieven.goeman@azdelta.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Urology
- Principal Investigator Name
- Nicolaas Lumen
- Principal Investigator Email
- nicolaas.lumen@uzgent.be
- Contact Person Name
- Nicolaas Lumen
- Contact Person Email
- nicolaas.lumen@uzgent.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Urology
- Principal Investigator Name
- Siska Van Bruwaene
- Principal Investigator Email
- siska.vanbruwaene@azgroeninge.be
- Contact Person Name
- Siska Van Bruwaene
- Contact Person Email
- siska.vanbruwaene@azgroeninge.be
France
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 09-08-2024
- Processing Time Days
- 64
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- Urology
- Principal Investigator Name
- Souhil LEBDAI
- Principal Investigator Email
- SoLebdai@chu-angers.fr
- Contact Person Name
- Souhil LEBDAI
- Contact Person Email
- SoLebdai@chu-angers.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Oncology
- Principal Investigator Name
- Hakim MAHAMMEDI
- Principal Investigator Email
- hakim.mahammedi@clermont.unicancer.fr
- Contact Person Name
- Hakim MAHAMMEDI
- Contact Person Email
- hakim.mahammedi@clermont.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sylvain LADOIRE
- Principal Investigator Email
- sladoire@cgfl.fr
- Contact Person Name
- Sylvain LADOIRE
- Contact Person Email
- sladoire@cgfl.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Urology
- Principal Investigator Name
- Jerome RIGAUD
- Principal Investigator Email
- jerome.rigaud@chu-nantes.fr
- Contact Person Name
- Jerome RIGAUD
- Contact Person Email
- jerome.rigaud@chu-nantes.fr
- Site Name
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Medical Oncology
- Principal Investigator Name
- Loïc JAFFRELOT
- Principal Investigator Email
- loic.jaffrelot@aphp.fr
- Contact Person Name
- Loïc JAFFRELOT
- Contact Person Email
- loic.jaffrelot@aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Benjamin AUBERGER
- Principal Investigator Email
- benjamin.auberger@chu-brest.fr
- Contact Person Name
- Benjamin AUBERGER
- Contact Person Email
- benjamin.auberger@chu-brest.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Emc Piaseczno Sp. z o.o.
- Department Name
- Szpital Św. Anny
- Principal Investigator Name
- Mieszko Kozikowski
- Principal Investigator Email
- mieszkokozikowski9@gmail.com
- Contact Person Name
- Mieszko Kozikowski
- Contact Person Email
- mieszkokozikowski9@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Chemioterapii
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 05-11-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 19
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Sofiamed OOD
- Department Name
- Department -Medical Oncology
- Principal Investigator Name
- Velko Minchev
- Principal Investigator Email
- v_minchev@abv.bg
- Contact Person Name
- Velko Minchev
- Contact Person Email
- v_minchev@abv.bg
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- Clinic - Medical Oncology
- Principal Investigator Name
- Kremena Vasileva
- Principal Investigator Email
- kre.ivanova@abv.bg
- Contact Person Name
- Kremena Vasileva
- Contact Person Email
- kre.ivanova@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Dobrich AD
- Department Name
- Department - Medical Oncology
- Principal Investigator Name
- Zyuhal Kasimova
- Principal Investigator Email
- dr.zyuhal.kasimova@gmail.com
- Contact Person Name
- Zyuhal Kasimova
- Contact Person Email
- dr.zyuhal.kasimova@gmail.com
- Site Name
- Multi-profile Hospital for Active Treatment Heart and Brain EAD
- Department Name
- Clinic of Medical Oncology
- Principal Investigator Name
- Nataliya Chilingirova
- Principal Investigator Email
- n.chilingirova.pn@heartandbrain.bg
- Contact Person Name
- Nataliya Chilingirova
- Contact Person Email
- n.chilingirova.pn@heartandbrain.bg
- Site Name
- MBAL Trakia EOOD
- Department Name
- Department - Medical Oncology Level III
- Principal Investigator Name
- Rumyana Ilieva
- Principal Investigator Email
- dr.rumyanailieva@gmail.com
- Contact Person Name
- Rumyana Ilieva
- Contact Person Email
- dr.rumyanailieva@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 33
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- Urologia
- Principal Investigator Name
- Nicola Pavan
- Principal Investigator Email
- nicola.pavan@unipa.it
- Contact Person Name
- Nicola Pavan
- Contact Person Email
- nicola.pavan@unipa.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- UOC Urologia
- Principal Investigator Name
- Giuseppe Simone
- Principal Investigator Email
- giuseppe.simone@ifo.it
- Contact Person Name
- Giuseppe Simone
- Contact Person Email
- giuseppe.simone@ifo.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Oncologia Medica urognitale e cervico facciale
- Principal Investigator Name
- Franco Nolè
- Principal Investigator Email
- franco.nole@ieo.it
- Contact Person Name
- Franco Nolè
- Contact Person Email
- franco.nole@ieo.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Luigi Formisano
- Principal Investigator Email
- Luigi.formisano1@unina.it
- Contact Person Name
- Luigi Formisano
- Contact Person Email
- Luigi.formisano1@unina.it
Lithuania
- Earliest CTIS Part Ii Submission Date
- 23-10-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 8
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
- Department Name
- Urology
- Principal Investigator Name
- Albertas Ulys
- Principal Investigator Email
- ieva.kasiliauskaite@nvc.santa.lt
- Contact Person Name
- Albertas Ulys
- Contact Person Email
- ieva.kasiliauskaite@nvc.santa.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Urology
- Principal Investigator Name
- Stasys Auškalnis
- Principal Investigator Email
- auskalnis74@gmail.com
- Contact Person Name
- Stasys Auškalnis
- Contact Person Email
- auskalnis74@gmail.com
Sponsor
Primary sponsor
- Full Name
- Debiopharm International SA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Medpace Finland Oy
- Responsibilities
- codes: 1,12,13,2,5
- Name
- IQVIA Limited
- Responsibilities
- code: 3
- Name
- Medidata Solutions Inc.
- Responsibilities
- code: 7
- Name
- SGS Belgium
- Responsibilities
- safety case processing, statistical analysis, clinical pharmacology; code: 6
- Name
- Charles River Laboratories Saint-Nazaire
- Responsibilities
- code: 4
- Name
- Calvagone
- Responsibilities
- population PK/PD analysis
- Name
- Firma Clinical Research
- Responsibilities
- home nursing
Third parties
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"codes: 1,12,13,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Charles River Laboratories Saint-Nazaire","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Calvagone","duties_or_roles":"population PK/PD analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"safety case processing, statistical analysis, clinical pharmacology; code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Firma Clinical Research","duties_or_roles":"home nursing","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Debio 4228
- Active Substance
- DEGARELIX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intramuscular
- Route
- Intramuscular
- Investigational Product Name
- Debio 4228
- Active Substance
- DEGARELIX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intramuscular injection
- Route
- Intramuscular injection
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