Clinical trial • Phase III • Oncology

18F-PSMA-1007 for Prostate cancer

Phase III trial of 18F-PSMA-1007 for Prostate cancer. None/Not specified-controlled. 80 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer
Trial Stage
Phase III
Drug Modality
Radiopharmaceutical|Diagnostic agent

Key dates

Initial CTIS Submission Date
04-09-2023
First CTIS Authorization Date
11-01-2024

Trial design

None/Not specified-controlled Phase III trial across 17 sites in France, Italy, Spain and others.

Comparator
None/Not specified
Target Sample Size
80

Eligibility

Recruits 80 Exclusion criterion: "The patient is part of a vulnerable population, e.g., but not limited to the patient is incapacitated in such a way that renders him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient". Inclusion requires the patient to be able to understand study information and to have provided written informed consent ("The patient is able to understand the information ... AND has provided written informed consent to participate"). No assent procedures are specified..

Vulnerable Population
Exclusion criterion: "The patient is part of a vulnerable population, e.g., but not limited to the patient is incapacitated in such a way that renders him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient". Inclusion requires the patient to be able to understand study information and to have provided written informed consent ("The patient is able to understand the information ... AND has provided written informed consent to participate"). No assent procedures are specified.

Inclusion criteria

  • {"criterion_text":"- The patient (male) is aged 18 years or above"}
  • {"criterion_text":"- The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate"}
  • {"criterion_text":"- The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment"}
  • {"criterion_text":"- The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following: Overall ISUP grade group 4 or 5, OR Clinical category T3a or greater, –OR Serum PSA level greater than 20 ng/ml."}
  • {"criterion_text":"- The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure"}

Exclusion criteria

  • {"criterion_text":"- Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection"}
  • {"criterion_text":"- The patient is clinically unstable or requires emergency treatment"}
  • {"criterion_text":"- The patient is part of a vulnerable population, e.g., but not limited to the patient is incapacitated in such a way that renders him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient"}
  • {"criterion_text":"- The patient has received any therapy – be it radiation, surgical or drug therapy – for his prostate cancer"}
  • {"criterion_text":"- The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007"}
  • {"criterion_text":"- The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan)"}
  • {"criterion_text":"- The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator"}
  • {"criterion_text":"- At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit"}
  • {"criterion_text":"- The patient has previously been enrolled in this trial"}
  • {"criterion_text":"- Confidential commercial information"}
  • {"criterion_text":"- The patient has histological evidence of small-cell carcinoma of the prostate"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Confidential commercial information","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
80
Recruitment Window Months
39
Consent Approach
Written informed consent is required from the patient: "The patient is able to understand the information ... AND has provided written informed consent to participate". Participants must be adult males (≥18 years). Subject information and ICF documents are provided in site languages (documents available for Italian, Spanish, Dutch and German). No assent pathway is described.

Geography

Total Number Of Sites
17
Total Number Of Participants
355

France

Earliest CTIS Part Ii Submission Date
30-10-2023
Latest Decision Or Authorization Date
12-01-2024
Processing Time Days
74
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
Centre Leon Berard
Department Name
Nuclear Medicine
Contact Person Name
Valentin Pretet
Site Name
CHRU De Nancy
Department Name
Nuclear Medicine
Contact Person Name
Pierre Olivier
Contact Person Email
p.olivier@chru-nancy.fr

Italy

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
25
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Nuclear Medicine
Contact Person Name
Federica Mateucci
Contact Person Email
federica.matteucci@irst.emr.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Nuclear Medicine
Contact Person Name
Matteo Salgarello

Spain

Earliest CTIS Part Ii Submission Date
11-10-2023
Latest Decision Or Authorization Date
11-01-2024
Processing Time Days
92
Number Of Sites
3
Number Of Participants
62

Sites

Site Name
Hospital Del Mar
Department Name
Nuclear Medicine
Contact Person Name
Pedro José Plaza López
Site Name
Hospital 9 De Octubre S.A.
Department Name
Nuclear Medicine
Contact Person Name
Pedro Sopena
Contact Person Email
pet@vithas.es
Site Name
Vall D Hebron Institute Of Research
Department Name
Nuclear Medicine
Contact Person Name
Marc Simo
Contact Person Email
marc.simo@vallhebron.cat

Netherlands

Earliest CTIS Part Ii Submission Date
24-11-2023
Latest Decision Or Authorization Date
18-10-2024
Processing Time Days
329
Number Of Sites
2
Number Of Participants
33

Sites

Site Name
Canisius Wilhelmina Hospital
Department Name
Urology
Contact Person Name
Diederik Somford
Contact Person Email
rick.hermsen@cwz.nl
Site Name
Stichting Radboud University Medical Center
Department Name
Nuclear Medicine
Contact Person Name
James) Nagarajah
Contact Person Email
James.Nagarajah@radboudumc.nl

Germany

Earliest CTIS Part Ii Submission Date
04-12-2023
Latest Decision Or Authorization Date
12-01-2024
Processing Time Days
39
Number Of Sites
8
Number Of Participants
248

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Nuclear Medicine
Contact Person Name
Susanne Klutmann
Contact Person Email
klutmann@uke.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Nuclear Medicine
Contact Person Name
Ralph Bundschuh
Contact Person Email
ralph.bundschuh@ukdd.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Nuclear Medicine
Contact Person Name
Frederik L. Giesel
Site Name
Rostock University Medical Center
Department Name
Nuclear Medicine
Contact Person Name
Martin Heuschkel
Site Name
Universitaet Leipzig
Department Name
Nuclear Medicine
Contact Person Name
Osama Sabri
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Nuclear Medicine
Contact Person Name
Matthias Eiber
Contact Person Email
matthias.eiber@tum.de
Site Name
St. Antonius-Hospital Gronau GmbH
Department Name
Nuclear Medicine
Contact Person Name
Kambiz Rahbar
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Nuclear Medicine
Contact Person Name
Kambiz Rahbar
Contact Person Email
Kambiz.Rahbar@ukmuenster.de

Sponsor

Primary sponsor

Full Name
Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Pharmtrace klinische Entwicklung GmbH
Responsibilities
Sponsor duties codes: [1,10,11,12,13,5,6,7]; contact email: eagle-i@pharmtrace.com

Third parties

  • {"country":"Germany","full_name":"Pharmtrace klinische Entwicklung GmbH","duties_or_roles":"[1,10,11,12,13,5,6,7]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RADELUMIN 2000 MBq/ml solution injectable
Active Substance
18F-PSMA-1007
Modality
Radiopharmaceutical|Diagnostic agent
Routes Of Administration
INJECTABLE SOLUTION
Route
INJECTABLE SOLUTION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
450 MBq
Investigational Product Name
RADELUMIN 1300 MBq/ml solution injectable
Active Substance
18F-PSMA-1007
Modality
Radiopharmaceutical|Diagnostic agent
Routes Of Administration
INJECTABLE SOLUTION
Route
INJECTABLE SOLUTION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
450 MBq

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