This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.
Potential patients for this study will be recruited by up to 15 centres specialised in prostate cancer. Study sites will be interdisciplinary, consisting of a uro-oncology sub-site, and a radiology sub-site with high-quality MRI, surgery and pathology. Study visits will be typically conducted at the recruiting sub-site, or as institutionally appropriate. Treatment visits for patients will be performed in the collaborating sub-site. Patients will be invited for study participation by the investigators in the context of specialised clinics. Interested patients will be provided with an information sheet and will undergo a detailed informed consent procedure prior to any study procedures. Recruitment will be continued until a sufficient number of patients have undergone Ferrotran® imaging and histopathological evaluation. To compensate for an expected drop-out rate of 15% to 20%, recruitment will only be stopped as soon as at least 69 evaluable positive (patients positive) and at least 104 evaluable negative (patients negative) patients are available for analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
172
Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min). Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care.
Universitair Ziekenhuis Ghent
Ghent, Belgium
Charité - Universitätsklinikum Berlin
Berlin, State of Berlin, Germany
Vivantes Klinikum Am Urban
Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.
Time frame: up to day 42
Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced).
Time frame: up to day 105
Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events)
Time frame: day 0 - day 105
Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI.
Time frame: up to day 105
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Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Köln
Cologne, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein Lübeck
Lübeck, Germany
...and 5 more locations