Clinical trial • Phase III • Oncology|Other
LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN for Metastatic hormone-sensitive prostate cancer
Phase III trial of LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN for Metastatic hormone-sensitive prostate cancer. Randomised, adaptive. 2914 participants.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Metastatic hormone-sensitive prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 29-10-2025
- First CTIS Authorization Date
- 25-02-2026
Trial design
Randomised, adaptive Phase III trial across 36 sites in Germany, Ireland, Spain.
- Randomised
- Yes
- Adaptive
- Yes
- Target Sample Size
- 2914
Eligibility
Recruits 2914 No vulnerable population selected; participants must be at least 18 years old and must sign the informed consent form for registration into the STAMPEDE2 platform. No assent or consent procedures for minors are described in the provided data..
- Vulnerable Population
- No vulnerable population selected; participants must be at least 18 years old and must sign the informed consent form for registration into the STAMPEDE2 platform. No assent or consent procedures for minors are described in the provided data.
Inclusion criteria
- {"criterion_text":"- I. At least 18 years old."}
- {"criterion_text":"- II. Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation."}
- {"criterion_text":"- III. Confirmation of metastatic site(s) on CT/MRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible: • Metastatic disease to the bone (in any distribution). • Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis. • Visceral metastases of any size or distribution."}
- {"criterion_text":"- IV. Clinical presentation is: A. de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI) will have been completed ≥2 years prior to any future randomisation into any of the comparisons, and; (3) will have received ≤3 years total of ADT at the point of randomisation into any comparison. Note: the dates will be checked again at randomisation. It is the responsibility of the investigator to account for the time between registration and randomisation into any comparison."}
- {"criterion_text":"- V. Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years."}
- {"criterion_text":"- VI. WHO Performance Status 0-2 or, if WHO Performance Status 3, deemed to be due to metastatic burden and expected to improve with ADT. Note: Improvement to WHO status 0-2 will be checked again at randomisation into any subsequent comparison."}
- {"criterion_text":"- VII. Willing and able to comply with trial treatments."}
- {"criterion_text":"- VIII. Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform."}
- {"criterion_text":"- *Listed above are the general inclusion criteria into the STAMPEDE2 platform, comparison specific eligibility criteria are listed in section 4 of the Master Protocol"}
Exclusion criteria
- {"criterion_text":"- I.\tClinically and pathologically overt small cell carcinoma."}
- {"criterion_text":"- II.\tMetastatic brain disease or leptomeningeal disease."}
- {"criterion_text":"- III.\tAny active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence)."}
- {"criterion_text":"- IV.\tAny other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long-term ADT or the trial treatments in the comparison for which they are being considered."}
- {"criterion_text":"- *Listed above are the general exclusion criteria into the STAMPEDE2 platform, comparison specific eligibility criteria are listed in section 4 of the Master Protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- For both Comparisons S and P, the primary outcome is Overall Survival (OS) defined as time from randomisation to death from any cause.","definition_or_measurement_approach":"Overall Survival (OS) defined as time from randomisation to death from any cause."}
Secondary endpoints
- {"endpoint_text":"- Failure-Free Survival (FFS), Radiographic Progression-Free-Survival (rPFS), Prostate cancer specific survival (PCSS), Safety, toxicity and compliance, Quality of life, Cost and resources.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 2914
- Recruitment Window Months
- 84
- Consent Approach
- Participants must sign an informed consent form prior to registration ('Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform'). Country-specific subject information and informed consent documents are provided (documents listed for Germany, Ireland, Spain and multi-language patient-facing documents including DE, ES, IT, IE and English versions). There are adult-specific ICFs; no assent for minors is described because enrollment is restricted to age ≥18.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 346
Germany
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 23
- Number Of Sites
- 9
- Number Of Participants
- 76
Sites
- Site Name
- Rostock University Medical Center
- Department Name
- Klinik und Poliklinik für Urologie
- Contact Person Name
- Angelika Borkowetz
- Contact Person Email
- angelika.borkowetz@med.uni-rostock.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Igor Tsaur
- Contact Person Email
- igor.tsaur@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Nuklearmedizin
- Contact Person Name
- Ken Herrmann
- Contact Person Email
- ken.herrmann@uk-essen.de
- Site Name
- Klinikum der Universität München Großhadern
- Department Name
- Urulogische Klinik und Poliklinik
- Contact Person Name
- Jozefina Casuscelli
- Contact Person Email
- jozefina.casuscelli@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Freiburg
- Department Name
- Klinik für Urologie
- Contact Person Name
- Markus Grabbert
- Contact Person Email
- markus.grabbert@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik und Poliklinik für Urologie
- Contact Person Name
- Marc-Oliver Grimm
- Contact Person Email
- marc-oliver.grimm@med.uni-jena.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Friedemann Zengerling
- Contact Person Email
- friedemann.zengerling@uniklinikum-ulm.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik für Urologie
- Contact Person Name
- Christian Thomas
- Contact Person Email
- christian.thomas.study@uniklinikum-dresden.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Klinik und Poliklinik für Nuklearmedizin
- Contact Person Name
- Matthias Eiber
- Contact Person Email
- matthias.eiber@tum.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 31
- Number Of Sites
- 9
- Number Of Participants
- 50
Sites
- Site Name
- Tallaght University Hospital
- Department Name
- Medical Oncology
- Contact Person Name
- Lynda Corrigan
- Contact Person Email
- lynda.corrigan@tuh.ie
- Site Name
- St Vincent's University Hospital
- Department Name
- Medical Oncology
- Contact Person Name
- Ray McDermott
- Contact Person Email
- ray.mcdermott@tuh.ie
- Site Name
- Beaumont Hospital
- Department Name
- Cancer Clinical Trials Unit
- Contact Person Name
- Min Yuen Teo
- Contact Person Email
- minyuentwo@beaumont.ie
- Site Name
- Cork University Hospital
- Department Name
- Cancer Trials Cork
- Contact Person Name
- Martin Higgins
- Contact Person Email
- martin.higgins@hse.ie
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Cancer Directorate Radiation Oncology
- Contact Person Name
- Martin O'Connell
- Contact Person Email
- oconnellm@mater.ie
- Site Name
- UPMC Hillman Cancer Centre, UPMC Whitfield Hospital
- Department Name
- Radiation Oncology Department
- Contact Person Name
- Ciara Lyons
- Contact Person Email
- lyonsc8@upmc.ie
- Site Name
- Saint Luke's Radiation Oncology Network
- Department Name
- St Luke's Radiation Oncology Network
- Contact Person Name
- Brian O'Neill
- Contact Person Email
- brian.oneill@slh.ie
- Site Name
- Tallaght University Hospital (duplicate entry region contact)
- Department Name
- Medical Oncology
- Contact Person Name
- Lynda Corrigan
- Contact Person Email
- lynda.corrigan@tuh.ie
- Site Name
- St Vincent's University Hospital (duplicate entry region contact)
- Department Name
- Medical Oncology
- Contact Person Name
- Ray McDermott
- Contact Person Email
- ray.mcdermott@tuh.ie
Spain
- Earliest CTIS Part Ii Submission Date
- 29-01-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 34
- Number Of Sites
- 18
- Number Of Participants
- 220
Sites
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Oncology
- Contact Person Name
- Silverio Ros
- Contact Person Email
- silverthegang@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Contact Person Name
- Bernardo Herrera Imbroda
- Contact Person Email
- ber.urologia@gmail.com
- Site Name
- Hospital Universitario Donostia
- Department Name
- Oncology
- Contact Person Name
- Amaya Hernández
- Contact Person Email
- ahernandez@onkologikoa.org
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Oncology
- Contact Person Name
- Iciar Garcia Carbonero
- Contact Person Email
- igcarbonero@yahoo.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Contact Person Name
- Urbano Anido Herranz
- Contact Person Email
- urbanoanido@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Contact Person Name
- Mikel Portu Grivé
- Contact Person Email
- mportu@santpau.cat
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Contact Person Name
- Alejo Rodriguez-Vida
- Contact Person Email
- arodriguezvida@hmar.cat
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Contact Person Name
- David Lorente Estellés
- Contact Person Email
- dlorente@fivo.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- Teresa Alonso Gordoa
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Josep María Piulats Rodríguez
- Contact Person Email
- jmpiulats@iconcologia.net
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Oncology
- Contact Person Name
- Ricardo Sánchez-Escribano
- Contact Person Email
- rsescribano@seom.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Daniel Castellano
- Contact Person Email
- cdanicas@hotmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Contact Person Name
- Javier Puente Vazquez
- Contact Person Email
- javierpuente.hcsc@gmail.com
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Contact Person Name
- Carlos Álvarez Fernández
- Contact Person Email
- carlos.alvfer@gmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Juan Francisco Rodriguez Moreno
- Contact Person Email
- jfrodriguez@hmhospitales.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Oncology
- Contact Person Name
- Rebeca Lozano
- Contact Person Email
- rebecalozano@saludcastillayleon.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Begoña Mellado
- Contact Person Email
- BMELLADO@clinic.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Contact Person Name
- Álvaro Pinto Marin
- Contact Person Email
- alvaro.pinto@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- University College London
- Organisation Type
- Educational Institution
- Country Of Registered Address
- United Kingdom
Third parties
- {"country":"","full_name":"Cancer Research UK","duties_or_roles":"Monetary support","organisation_type":""}
- {"country":"","full_name":"Advanced Accelerator Applications (ADACAP) / Novartis","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Pluvicto 1 000 MBq/mL solution for injection/infusion
- Active Substance
- LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation EU (EU/1/22/1703/001)
- Maximum Dose
- Max daily dose 7.4 GBq; max total dose 44.4 GBq
- Combination Treatment
- Yes
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