[18F]PSMA-1007 PET CT in patients with newly-diagnosed prostate cancer
Key facts
- Where
- Dresden, Duesseldorf, Gronau (Westf.), Hamburg, Leipzig, Muenster, Munich és Rostock, NémetországSee the 8 sites
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, NémetországTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, NémetországTaking people
- St. Antonius-Hospital Gronau GmbHGronau (Westf.), NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Universitaet LeipzigLeipzig, NémetországTaking people
- Universitaetsklinikum Muenster AöRMuenster, NémetországTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, NémetországTaking people
- Rostock University Medical CenterRostock, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
- Trial code
- EU 2023-504026-19-01
- Record updated
- 2026. szeptember 4.
- Original description
To assess, in an independent assessment by 3 readers blinded to the clinical data, the sensitivity and specificity of [18F]PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in newly diagnosed high-risk and very-high-risk prostate cancer (region-based patient-level analysis, at least one hemi-pelvis is correctly diagnosed), using histology as the standard of reference.Read full original descriptionShow less
Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer
To assess, in an independent assessment by 3 readers blinded to the clinical data, the sensitivity and specificity of [18F]PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in newly diagnosed high-risk and very-high-risk prostate cancer (region-based patient-level analysis, at least one hemi-pelvis is correctly diagnosed), using histology as the standard of reference.
Inclusion: The patient (male) is aged 18 years or above; 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; 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; 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; 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: The patient has received any therapy – be it radiation, surgical or drug therapy – for his prostate cancer; 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; The patient has previously been enrolled in this trial; The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007; 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; The patient is clinically unstable or requires emergency treatment; 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; 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); The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator; Confidential commercial information; The patient has histological evidence of small-cell carcinoma of the prostate.