Clinical trial • Phase III • Oncology
64CU-PSMA I&T for Prostate cancer | Prostate adenocarcinoma
Phase III trial of 64CU-PSMA I&T for Prostate cancer | Prostate adenocarcinoma. open-label, none/not specified-controlled. 173 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Prostate cancer | Prostate adenocarcinoma
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 16-09-2024
Trial design
open-label, none/not specified-controlled Phase III trial in France, Italy, Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 173
Eligibility
Recruits 173 Vulnerable population not selected. Participants must be able to understand and provide signed written informed consent; only adult males (≥18 years) are eligible, so assent/parental consent are not applicable..
- Vulnerable Population
- Vulnerable population not selected. Participants must be able to understand and provide signed written informed consent; only adult males (≥18 years) are eligible, so assent/parental consent are not applicable.
Inclusion criteria
- {"criterion_text":"- 1. Patients with histologically proven prostate adenocarcinoma."}
- {"criterion_text":"- 2. Planned prostatectomy with pelvic lymph node dissection."}
- {"criterion_text":"- 3. Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions."}
- {"criterion_text":"- 4. Male aged ≥18 years."}
- {"criterion_text":"- 5. Able to understand and provide signed written informed consent."}
Exclusion criteria
- {"criterion_text":"- 1. Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against PC prior to prostatectomy."}
- {"criterion_text":"- 2. Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration."}
- {"criterion_text":"- 3. Patients with any medical condition or circumstance (including receiving an IP or capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements."}
- {"criterion_text":"- 4. Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer < within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan."}
- {"criterion_text":"- 5. Patients who are administered any high energy (>300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration."}
- {"criterion_text":"- 6. Patients with known hypersensitivity to the active substance or any of the excipients of the IP."}
- {"criterion_text":"- 7. Patients who had a PSMA PET as part of their standard medical care within 90 days prior to enrollment"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. The sensitivity of copper Cu 64 PSMA I&T PET/CT to determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.","definition_or_measurement_approach":"Sensitivity measured at patient level versus histopathology reference standard; at least one positive pelvic lymph node on PET and one positive lymph node by histopathology on same side counts as true positive."}
- {"endpoint_text":"- 2. The specificity of copper Cu 64 PSMA I&T PET/CT to determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.","definition_or_measurement_approach":"Specificity measured at patient level versus histopathology reference standard; negative PET lymph node and negative histopathology on same side counts as true negative."}
Secondary endpoints
- {"endpoint_text":"- 1. Reader kappa statistics of copper Cu 64 PSMA I&T PET/CT scan interpretation by the blinded independent readers.","definition_or_measurement_approach":"Inter- and intra-reader agreement evaluated using kappa statistics by blinded independent readers on a per-patient basis."}
- {"endpoint_text":"- 2. Treatment-emergent adverse events from the time of IP administration up to 72 hours.","definition_or_measurement_approach":"Safety assessment by recording treatment-emergent adverse events from IP administration up to 72 hours."}
Recruitment
- Planned Sample Size
- 173
- Recruitment Window Months
- 8
- Consent Approach
- Participants must be able to understand and provide signed written informed consent (inclusion criterion). Only adult males (≥18 years) are eligible. No additional information on assent, parental consent, or languages provided.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 150
France
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 31
- Number Of Sites
- 15
- Number Of Participants
- 76
Sites
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Thibaut Reichert
- Principal Investigator Email
- reichertt@ipc.unicancer.fr
- Contact Person Name
- Thibaut Reichert
- Contact Person Email
- reichertt@ipc.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Caroline Rousseau
- Principal Investigator Email
- caroline.rousseau@ico.unicancer.fr
- Contact Person Name
- Caroline Rousseau
- Contact Person Email
- caroline.rousseau@ico.unicancer.fr
- Site Name
- Clinique Victor Hugo
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Eric Gontier
- Principal Investigator Email
- e.gontier@ilcgroupe.fr
- Contact Person Name
- Eric Gontier
- Contact Person Email
- e.gontier@ilcgroupe.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Alexandre Cochet
- Principal Investigator Email
- ACochet@cgfl.fr
- Contact Person Name
- Alexandre Cochet
- Contact Person Email
- ACochet@cgfl.fr
- Site Name
- CHRU De Nancy
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Pierre Olivier
- Principal Investigator Email
- p.olivier@chru-nancy.fr
- Contact Person Name
- Pierre Olivier
- Contact Person Email
- p.olivier@chru-nancy.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Desiree Deandreis
- Principal Investigator Email
- desiree.deandreis@gustaveroussy.fr
- Contact Person Name
- Desiree Deandreis
- Contact Person Email
- desiree.deandreis@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Loic Djaileb
- Principal Investigator Email
- ldjaileb@chu-grenoble.fr
- Contact Person Name
- Loic Djaileb
- Contact Person Email
- ldjaileb@chu-grenoble.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Francois Somme
- Principal Investigator Email
- f.somme@icans.eu
- Contact Person Name
- Francois Somme
- Contact Person Email
- f.somme@icans.eu
- Site Name
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Alban Bailliez
- Principal Investigator Email
- Bailliez.Alban@ghicl.net
- Contact Person Name
- Alban Bailliez
- Contact Person Email
- Bailliez.Alban@ghicl.net
- Site Name
- Centre Hospital Region Metz Thionville
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Sinan Ben Mahmoud
- Principal Investigator Email
- sinan.ben-mahmoud@chr-metz-thionville.fr
- Contact Person Name
- Sinan Ben Mahmoud
- Contact Person Email
- sinan.ben-mahmoud@chr-metz-thionville.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Vincent Boudousq
- Principal Investigator Email
- vincent.boudousq@chu-nimes.fr
- Contact Person Name
- Vincent Boudousq
- Contact Person Email
- vincent.boudousq@chu-nimes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Francois Rouzet
- Principal Investigator Email
- francois.rouzet@aphp.fr
- Contact Person Name
- Francois Rouzet
- Contact Person Email
- francois.rouzet@aphp.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Charles Merlin
- Principal Investigator Email
- charles.merlin@clermont.unicancer.fr
- Contact Person Name
- Charles Merlin
- Contact Person Email
- charles.merlin@clermont.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Fabien Hyafil
- Principal Investigator Email
- fabien.hyafil@aphp.fr
- Contact Person Name
- Fabien Hyafil
- Contact Person Email
- fabien.hyafil@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Medecine nucleaire
- Principal Investigator Name
- Mathieu Roumiguie
- Principal Investigator Email
- roumiguie.m@chu-toulouse.fr
- Contact Person Name
- Mathieu Roumiguie
- Contact Person Email
- roumiguie.m@chu-toulouse.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 23-09-2024
- Processing Time Days
- 90
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Dipartimento Medicina Nucleare
- Principal Investigator Name
- Paola Anna Erba
- Principal Investigator Email
- paolaanna.erba@unimib.it
- Contact Person Name
- Paola Anna Erba
- Contact Person Email
- paolaanna.erba@unimib.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- S.C. Divisione di Medicina Nucleare
- Principal Investigator Name
- Francesco Ceci
- Principal Investigator Email
- francesco.ceci@ieo.it
- Contact Person Name
- Francesco Ceci
- Contact Person Email
- francesco.ceci@ieo.it
- Site Name
- Ente Ospedaliero Ospedali Galliera Di Genova
- Department Name
- S.C. Medicina Nucleare
- Principal Investigator Name
- Arnoldo Piccardo
- Principal Investigator Email
- arnoldo.piccardo@galliera.it
- Contact Person Name
- Arnoldo Piccardo
- Contact Person Email
- arnoldo.piccardo@galliera.it
Spain
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 16-09-2024
- Processing Time Days
- 7
- Number Of Sites
- 13
- Number Of Participants
- 58
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Regina Girones Sarrio
- Principal Investigator Email
- girones_reg@gva.es
- Contact Person Name
- Regina Girones Sarrio
- Contact Person Email
- girones_reg@gva.es
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Diego Becerra Garcia
- Principal Investigator Email
- diego.becerra.sspa@juntadeandalucia.es
- Contact Person Name
- Diego Becerra Garcia
- Contact Person Email
- diego.becerra.sspa@juntadeandalucia.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Marcos Tajahuerce Romera
- Principal Investigator Email
- mtajahuerce@fivo.org
- Contact Person Name
- Marcos Tajahuerce Romera
- Contact Person Email
- mtajahuerce@fivo.org
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Pilar Tamayo Alonso
- Principal Investigator Email
- ptamayo@saludcastillayleon.es
- Contact Person Name
- Pilar Tamayo Alonso
- Contact Person Email
- ptamayo@saludcastillayleon.es
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Ana Maria Garcia Vicente
- Principal Investigator Email
- angarvice@yahoo.es
- Contact Person Name
- Ana Maria Garcia Vicente
- Contact Person Email
- angarvice@yahoo.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Lina Garcia Cañamaque
- Principal Investigator Email
- lgarciacanamaque@hmhospitales.com
- Contact Person Name
- Lina Garcia Cañamaque
- Contact Person Email
- lgarciacanamaque@hmhospitales.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Macarena Rodríguez
- Principal Investigator Email
- mrodriguez@unav.es
- Contact Person Name
- Macarena Rodríguez
- Contact Person Email
- mrodriguez@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Imanol Martinez
- Principal Investigator Email
- imanol.martinez@quironsalud.es
- Contact Person Name
- Imanol Martinez
- Contact Person Email
- imanol.martinez@quironsalud.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Antonio Gutierrez Cardo
- Principal Investigator Email
- antoniol.gutierrez.sspa@juntadeandalucia.es
- Contact Person Name
- Antonio Gutierrez Cardo
- Contact Person Email
- antoniol.gutierrez.sspa@juntadeandalucia.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Jose Manuel Jiménez-Hoyuela
- Principal Investigator Email
- josem.jimenezhoyuela.sspa@juntadeandalucia.es
- Contact Person Name
- Jose Manuel Jiménez-Hoyuela
- Contact Person Email
- josem.jimenezhoyuela.sspa@juntadeandalucia.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Macarena Rodríguez
- Principal Investigator Email
- mrodriguez@unav.es
- Contact Person Name
- Macarena Rodríguez
- Contact Person Email
- mrodriguez@unav.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- María de los Remedios Quirce
- Principal Investigator Email
- mremedios.quirce@scsalud.es
- Contact Person Name
- María de los Remedios Quirce
- Contact Person Email
- mremedios.quirce@scsalud.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Medicina Nuclear
- Principal Investigator Name
- Juan Antonio Vallejo Casas
- Principal Investigator Email
- jantonio.vallejo.sspa@juntadeandalucia.es
- Contact Person Name
- Juan Antonio Vallejo Casas
- Contact Person Email
- jantonio.vallejo.sspa@juntadeandalucia.es
Sponsor
Primary sponsor
- Full Name
- Curium US LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- WCG Clinical Inc.
- Name
- Syneos Health Netherlands B.V.
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Cis Bio International","duties_or_roles":"Manufacturing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Invicro LLC","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Intercash Prepaid Limited","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- 64Cu-PSMA I&T
- Active Substance
- 64CU-PSMA I&T
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Maximum Dose
- 8.8 mCi
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