Clinical trial • Phase III • Oncology
LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN for Metastatic castration-resistant prostate cancer (PSMA-positive)
Phase III trial of LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN for Metastatic castration-resistant prostate cancer (PSMA-positive).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer (PSMA-positive)
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical|Diagnostic agent|Small molecule
Key dates
- Initial CTIS Submission Date
- 08-12-2023
- First CTIS Authorization Date
- 30-01-2024
Trial design
Randomised, open-label, change of androgen receptor-directed therapy (ardt) — abiraterone acetate (oral; max daily dose listed in product data 1000 mg) or enzalutamide (oral; max daily dose listed in product data 160 mg).-controlled, crossover Phase III trial in Belgium, Czechia, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Change of androgen receptor-directed therapy (ARDT) — abiraterone acetate (oral; max daily dose listed in product data 1000 mg) or enzalutamide (oral; max daily dose listed in product data 160 mg).
- Crossover
- Yes
- Target Sample Size
- 177
Eligibility
Recruits 177 Participants must be adults ≥ 18 years of age; signed informed consent must be obtained prior to participation. The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Child assent documents appear in the document list for some languages but children are excluded by age criteria; assent is therefore not applicable for enrolled participants..
- Pregnancy Exclusion
- Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF
- Vulnerable Population
- Participants must be adults ≥ 18 years of age; signed informed consent must be obtained prior to participation. The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Child assent documents appear in the document list for some languages but children are excluded by age criteria; assent is therefore not applicable for enrolled participants.
Inclusion criteria
- {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study\n- Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, etc.) except alopecia\n- Participants must have adequate organ function: Bone marrow reserve: • ANC ≥ 1.5 x 109/L • Platelets ≥100 x 109/L • Hemoglobin ≥ 9 g/dL Hepatic: • Total bilirubin < 2 x the institutional upper limit of normal (ULN). For participants with known Gilbert’s Syndrome ≤ 3 x ULN is permitted • ALT or AST ≤ 3.0 x ULN OR ≤ 5.0 x ULN for participants with liver metastases Renal: • eGFR ≥ 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation\n- Albumin ≥ 2.5 g/dL\n- Candidates for change in ARDT as assessed by the treating physician • Participants cannot have previously progressed nor had intolerable toxicity to both enzalutamide and abiraterone.\n- Participants must be adults ≥ 18 years of age\n- Participants must have an ECOG performance status of 0 to 1\n- Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate\n- Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor’s central reader\n- Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L)\n- Participants must have progressed only once on prior second generation ARDT (abiraterone, enzalutamide, darolutamide, or apalutamide). first generation androgen receptor inhibitor therapy (e.g. bicalutamide) is allowed but not considered as prior ARDT therapy • second generation ARDT must be the most recent therapy received\n- Participants must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: • Serum/plasma PSA progression defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression. • Soft-tissue progression defined [PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)] • Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016))\n- Participants must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained prior to randomization"}
Exclusion criteria
- {"criterion_text":"- Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation\n- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression\n- Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. • HIV-infected participants who are at a low risk of AIDS-related outcomes may participate in this trial. • Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance).\n- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free and treatment free for more than 3 years prior to randomization, are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer\n- Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF\n- Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: Participant with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed.\n- History or current diagnosis of the following ECG abnormalities indicating significant risk of safety for study participants: • Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) • History of familial long QT syndrome or known family history of Torsades de Pointe • Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or CABG within 6 months prior to starting study treatment\n- Previous PSMA-targeted radioligand therapy\n- Prior treatment with cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed]\n- Not able to understand and to comply with study instructions and requirements\n- Any investigational agents within 28 days prior to day of randomization\n- Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar classes\n- Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy\n- Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for study inclusion\n- Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.\n- History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study\n- Any condition that precludes raised arms position\n- Eligible for treatment(s) other than ARDT based on presence of any mutations or biomarkers that are known as predictors of better response (e.g., AR-V7 or BRCA)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Radiographic progression-free survival (rPFS) is defined as the time from the date of randomization to the date of first documented radiographic disease progression as assessed by blinded independent central review (BICR) and as outlined in Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al 2016) or death due to any cause.","definition_or_measurement_approach":"Time from randomization to first documented radiographic disease progression assessed by blinded independent central review (BICR) per PCWG3-modified RECIST v1.1, or death from any cause."}
Secondary endpoints
- {"endpoint_text":"- OS: Time from randomization to death due to any cause","definition_or_measurement_approach":"Overall survival (OS): time from randomization to death from any cause."}
- {"endpoint_text":"- rPFS2 defined as time from the date of crossover (ARDT to 177Lu-PSMA-617) to the date of radiographic disease progression by BICR or death from any cause [rPFS definition as outlined in PCWG3 guidelines]","definition_or_measurement_approach":"Time from date of crossover to radiographic progression per BICR or death; uses PCWG3 rPFS definitions."}
- {"endpoint_text":"- PFS defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic, clinical, or PSA progression) or death from any cause, whichever occurs first","definition_or_measurement_approach":"Investigator-assessed progression-free survival (PFS): time from randomization to first documented progression (radiographic, clinical, or PSA) or death."}
- {"endpoint_text":"- PFS2 defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first, on next-line of therapy","definition_or_measurement_approach":"Time from randomization to first investigator-documented progression or death on next-line therapy."}
- {"endpoint_text":"- PSA50 defined as proportion of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second PSA measurement ≥ 4 weeks. PSA50 will be evaluated at 3, 6 and 12 months.","definition_or_measurement_approach":"Biochemical response: proportion with ≥50% PSA decline from baseline confirmed by a second measurement ≥4 weeks; evaluated at months 3, 6, 12."}
- {"endpoint_text":"- Time to SSE (TTSSE) defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from randomization to first symptomatic skeletal event (pathologic fracture, spinal cord compression, tumor-related orthopedic surgery, radiation to bone pain) or death."}
- {"endpoint_text":"- Time to soft tissue progression (TTSTP) defined as time from randomization to radiographic soft tissue progression per PCWG3-modified RECIST v1.1 (Soft Tissue Rules of Prostate Cancer Working Group modified Response Evaluation Criteria in Solid Tumors Version 1.1) as Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"Time from randomization to radiographic soft-tissue progression assessed by BICR using PCWG3-modified RECIST v1.1."}
- {"endpoint_text":"- Time to chemotherapy (TTCT) defined as time from randomization to initiation of the first subsequent chemotherapy or death, whichever occurs first","definition_or_measurement_approach":"Time from randomization to start of first subsequent chemotherapy or death."}
- {"endpoint_text":"- HRQoL as assessed by EQ-5D-5L, FACT-P and BPI-SF","definition_or_measurement_approach":"Health-related quality of life measured using EQ-5D-5L, FACT-P, and BPI-SF instruments."}
- {"endpoint_text":"- Frequency of adverse events, safety laboratory assessments and vital signs","definition_or_measurement_approach":"Safety endpoints: incidence and frequency of adverse events, safety laboratory abnormalities, and vital signs per standard reporting (CTCAE)."}
Recruitment
- Planned Sample Size
- 177
- Recruitment Window Months
- 51
- Consent Approach
- Signed informed consent must be obtained prior to participation. All participants are adults (≥18 years). Subject information and informed consent forms (ICFs), separate data protection consents, partner information sheets and follow-up documents are provided; ICFs are available in multiple languages (documents list includes English, Czech, French, Spanish, German, Dutch, Swedish, Slovak and others). Child assent documents appear in the document list for some languages but children are excluded by the age criteria.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 334
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 706
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- 1050: Urology
- Principal Investigator Name
- Bertrand Tombal
- Principal Investigator Email
- bertrand.tombal@fymu.ucl.ac.be
- Contact Person Name
- Bertrand Tombal
- Contact Person Email
- bertrand.tombal@fymu.ucl.ac.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- 1052: 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 Delta
- Department Name
- 1054: Department of Nuclear Medicine
- Principal Investigator Name
- Kristoff Muylle
- Principal Investigator Email
- Kristoff.Muylle@azdelta.be
- Contact Person Name
- Kristoff Muylle
- Contact Person Email
- Kristoff.Muylle@azdelta.be
- Site Name
- CHU De Liege
- Department Name
- 1055: Service Oncologie Médicale
- Principal Investigator Name
- Nadia Withofs
- Principal Investigator Email
- nwithofs@chuliege.be
- Contact Person Name
- Nadia Withofs
- Contact Person Email
- nwithofs@chuliege.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 679
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- 1100: Onkologická klinika
- Principal Investigator Name
- Hana Študentová
- Principal Investigator Email
- hana.studentova@fnol.cz
- Contact Person Name
- Hana Študentová
- Contact Person Email
- hana.studentova@fnol.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 679
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- #1252: Klinik und Poliklinik für Nuklearmedizin
- Principal Investigator Name
- Matthias Eiber
- Principal Investigator Email
- Matthias.eiber@tum.de
- Contact Person Name
- Matthias Eiber
- Contact Person Email
- Matthias.eiber@tum.de
- Site Name
- Rostock University Medical Center
- Department Name
- #1250:Klinik und Poliklinik für Nuklearmedizin
- Principal Investigator Name
- Bernd Krause
- Principal Investigator Email
- Bernd.krause@med.uni-rostock.de
- Contact Person Name
- Bernd Krause
- Contact Person Email
- Bernd.krause@med.uni-rostock.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- #1251: Klinik für Nuklearmedizin
- Principal Investigator Name
- Ken Herrmann
- Principal Investigator Email
- Ken.hermann@uk-essen.de
- Contact Person Name
- Ken Herrmann
- Contact Person Email
- Ken.hermann@uk-essen.de
France
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 679
- Number Of Sites
- 6
- Number Of Participants
- 97
Sites
- Site Name
- Centre Leon Berard
- Department Name
- #1200: Oncologie Medicale
- Principal Investigator Name
- Aude FLECHON
- Principal Investigator Email
- aude.flechon@lyon.unicancer.fr
- Contact Person Name
- Aude FLECHON
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
- Site Name
- Centre Jean Perrin
- Department Name
- #1202: Oncologie
- 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
- Institut De Cancerologie De L Ouest
- Department Name
- #1205: Medecine Nucleaire
- Principal Investigator Name
- Olivier MOREL
- Principal Investigator Email
- olivier.morel@ico.unicancer.fr
- Contact Person Name
- Olivier MOREL
- Contact Person Email
- olivier.morel@ico.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- #1203: Oncologie urologique
- Principal Investigator Name
- Guilhem ROUBAUD
- Principal Investigator Email
- g.roubaud@bordeaux.unicancer.fr
- Contact Person Name
- Guilhem ROUBAUD
- Contact Person Email
- g.roubaud@bordeaux.unicancer.fr
- Site Name
- Hopital Tenon
- Department Name
- #1204: Oncologie Medicale
- Principal Investigator Name
- Ahmed KHALIL
- Principal Investigator Email
- ahmed.khalil@aphp.fr
- Contact Person Name
- Ahmed KHALIL
- Contact Person Email
- ahmed.khalil@aphp.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- #1201: Nuclear Medicine
- Principal Investigator Name
- Désirée DEANDREIS
- Principal Investigator Email
- desiree.deandreis@gustaveroussy.fr
- Contact Person Name
- Désirée DEANDREIS
- Contact Person Email
- desiree.deandreis@gustaveroussy.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 679
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- University Hospital Maastricht
- Department Name
- #1351: Medical Oncology
- Principal Investigator Name
- Thomas Kerkhofs
- Principal Investigator Email
- Thomas.kerkhofs@mumc.nl
- Contact Person Name
- Thomas Kerkhofs
- Contact Person Email
- Thomas.kerkhofs@mumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- #1352:Department of Radiology and Nuclear medicine
- Principal Investigator Name
- Marnix Lam
- Principal Investigator Email
- m.lam@umcutrrecht.nl
- Contact Person Name
- Marnix Lam
- Contact Person Email
- m.lam@umcutrrecht.nl
- Site Name
- Stichting Radboud University Medical Center
- Department Name
- #1350: Department of Radiology and Nuclear Medicine
- Principal Investigator Name
- James Nagarajah
- Principal Investigator Email
- James.Nagarajah@radboudumc.nl
- Contact Person Name
- James Nagarajah
- Contact Person Email
- James.Nagarajah@radboudumc.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 685
- Number Of Sites
- 13
- Number Of Participants
- 154
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- 1512: Oncology
- Principal Investigator Name
- Begoña Pérez Valderrama
- Principal Investigator Email
- mbegona.perez.sspa@juntadeandalucia.es
- Contact Person Name
- Begoña Pérez Valderrama
- Contact Person Email
- mbegona.perez.sspa@juntadeandalucia.es
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- 1510: Oncology
- Principal Investigator Name
- Silverio Ros Martínez
- Principal Investigator Email
- silverio.ros@carm.es
- Contact Person Name
- Silverio Ros Martínez
- Contact Person Email
- silverio.ros@carm.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- 1508: Oncology
- Principal Investigator Name
- Miguel Ángel Climent Durán
- Principal Investigator Email
- macliment@fivo.org
- Contact Person Name
- Miguel Ángel Climent Durán
- Contact Person Email
- macliment@fivo.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- 1504: Oncology
- Principal Investigator Name
- Daniel Castellano Gauna
- Principal Investigator Email
- daniel.castellano@salud.madrid.org
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- daniel.castellano@salud.madrid.org
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- 1506: Oncology
- Principal Investigator Name
- José Ángel Arranz Arija
- Principal Investigator Email
- joseangel.arranz@salud.madrid.org
- Contact Person Name
- José Ángel Arranz Arija
- Contact Person Email
- joseangel.arranz@salud.madrid.org
- Site Name
- Hospital Clinico San Carlos
- Department Name
- 1505: Oncology
- Principal Investigator Name
- Javier Puente Vázquez
- Principal Investigator Email
- javier.puente@salud.madrid.org
- Contact Person Name
- Javier Puente Vázquez
- Contact Person Email
- javier.puente@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- 1501: Oncology
- Principal Investigator Name
- Jose Pablo Maroto Rey
- Principal Investigator Email
- jmaroto@santpau.cat
- Contact Person Name
- Jose Pablo Maroto Rey
- Contact Person Email
- jmaroto@santpau.cat
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 1502: Oncology
- Principal Investigator Name
- Begoña Mellado González
- Principal Investigator Email
- BMELLADO@clinic.cat
- Contact Person Name
- Begoña Mellado González
- Contact Person Email
- BMELLADO@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 1500: Oncology
- Principal Investigator Name
- David Humberto Marmolejo Castañeda
- Principal Investigator Email
- davidmarmolejo@vhio.net
- Contact Person Name
- David Humberto Marmolejo Castañeda
- Contact Person Email
- davidmarmolejo@vhio.net
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- 1507: Oncology
- Principal Investigator Name
- Aranzazu Gonzalez del Alba Bahamonde
- Principal Investigator Email
- aranzazu.gonzalezalba@salud.madrid.org
- Contact Person Name
- Aranzazu Gonzalez del Alba Bahamonde
- Contact Person Email
- aranzazu.gonzalezalba@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- 1511: Oncology
- Principal Investigator Name
- Álvaro Montesa Pino
- Principal Investigator Email
- alvarog.montesa.sspa@juntadeandalucia.es
- Contact Person Name
- Álvaro Montesa Pino
- Contact Person Email
- alvarog.montesa.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- 1509: Oncology
- Principal Investigator Name
- Regina Gironés Sarrió
- Principal Investigator Email
- girones_reg@gva.es
- Contact Person Name
- Regina Gironés Sarrió
- Contact Person Email
- girones_reg@gva.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- 1513: Oncology
- Principal Investigator Name
- Jose Luis Pérez Gracia
- Principal Investigator Email
- jlgracia@unav.es
- Contact Person Name
- Jose Luis Pérez Gracia
- Contact Person Email
- jlgracia@unav.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 685
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- 1552: VE Onkologi
- Principal Investigator Name
- Carl-Fredrik Warfvinge
- Principal Investigator Email
- carl_fredrik.warfvinge@med.lu.se
- Contact Person Name
- Carl-Fredrik Warfvinge
- Contact Person Email
- carl_fredrik.warfvinge@med.lu.se
- Site Name
- Sahlgrenska University Hospital-Vastra Gotalandsregionen
- Department Name
- 1550: Onkologkliniken
- Principal Investigator Name
- Claes Molin
- Principal Investigator Email
- claes.molin@vgregion.se
- Contact Person Name
- Claes Molin
- Contact Person Email
- claes.molin@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- 1551: Mottagning för urologiska sjukdomar
- Principal Investigator Name
- Enrique Castellanos
- Principal Investigator Email
- enrique.castellanos@regionstockholm.se
- Contact Person Name
- Enrique Castellanos
- Contact Person Email
- enrique.castellanos@regionstockholm.se
Austria
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 685
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- University Clinic for Urology
- Principal Investigator Name
- Gero Kramer
- Principal Investigator Email
- gero.kramer@meduniwien.ac.at
- Contact Person Name
- Gero Kramer
- Contact Person Email
- gero.kramer@meduniwien.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Urology and Andrology
- Principal Investigator Name
- Ferdinand Luger
- Principal Investigator Email
- ferdinand.luger@ordensklinikum.at
- Contact Person Name
- Ferdinand Luger
- Contact Person Email
- ferdinand.luger@ordensklinikum.at
Slovakia
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 777
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Narodny Onkologicky Ustav
- Department Name
- 1450: II. Onkologická klinika LFUK a NOÚ | Klinika klinickej onkológie SZU a NOÚ
- Principal Investigator Name
- Michal Mego
- Principal Investigator Email
- michal.mego@nou.sk
- Contact Person Name
- Michal Mego
- Contact Person Email
- michal.mego@nou.sk
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA RDS Spain S.L.
- Name
- IQVIA Limited
- Name
- Bioclinica Inc.
- Responsibilities
- Central Imaging
- Name
- Syneos Health Clinical Spain S.L.
- Name
- WCG Clinical Inc.
- Responsibilities
- DMC
Third parties
- {"country":"Czechia","full_name":"Masarykuv Onkologicky Ustav","duties_or_roles":"68Ga-PSMA-11 preparation and administration, diagnostic via PET/CT","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Spain","full_name":"IQVIA RDS Spain S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Spain","full_name":"Advanced Accelerator Applications Molecular Imaging Iberica S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Tjoapack Netherlands B.V.","duties_or_roles":"Ancillary Labeling Site","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"DMC","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"Biomarker analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Rps Research Iberica S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Curium Pharma Spain S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Invicro LLC","duties_or_roles":"Quantitative imaging data","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Syneos Health Clinical Spain S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Patient Reported Outcomes (PRO) & Electronic Patient Reported Outcomes ((e)PRO) formatting, translations, and licensing","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Alliance Healthcare Nederland B.V.","duties_or_roles":"IMP supplier","organisation_type":"Pharmaceutical company"}
- {"country":"Slovakia","full_name":"Biont a.s.","duties_or_roles":"68Ga-PSMA-11 preparation and administration, diagnostic via PET/CT","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Oriola Sweden AB","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Slovakia","full_name":"Onkologicky Ustav Sv Alzbety s.r.o.","duties_or_roles":"177Lu-PSMA-617 administration","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Portugal","full_name":"Advanced Accelerator Applications (Portugal) Unipessoal Lda.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies (duplicate entry noted)","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Oriola Sweden AB (duplicate entry noted)","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Fundacion General De La Universidad De Malaga","duties_or_roles":"","organisation_type":"Patient organisation/association"}
- {"country":"Spain","full_name":"Rps Research Iberica S.L. (duplicate entry noted)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Slovakia","full_name":"Biont a.s. (duplicate entry noted)","duties_or_roles":"68Ga-PSMA-11 preparation and administration, diagnostic via PET/CT","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies (additional entry)","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Oriola Sweden AB (additional entry)","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
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 authorised (EU) (EU/1/22/1703/001)
- Maximum Dose
- 7.4 GBq
- Investigational Product Name
- Locametz 25 micrograms kit for radiopharmaceutical preparation
- Active Substance
- GOZETOTIDE
- Modality
- Diagnostic agent
- Routes Of Administration
- INTRAVENOUS (after labelling/preparation)
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorised (EU) (EU/1/22/1692/001)
- Maximum Dose
- 150 MBq
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