Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
Reason given: The study was closed prematurely in order to finalise it under EU directive 2001/20/EC, without transitioning to EU-CTR, and avoiding unnecessary delay of the marketing authorisation application.
Key facts
- Where
- Berlin, Bonn, Cologne, Dresden, Düsseldorf, Essen, Leipzig, Lübeck, and Mannheim, GermanySee the 10 sites
- Phase
- Phase 3
Where in Germany
- Charite- Universitätsklinikum BerlinBerlin, GermanyNo longer taking part
- Vivantes Klinikum am UrbanBerlin, GermanyNo longer taking part
- Universitätsklinikum BonnBonn, GermanyNo longer taking part
- Universitätsklinikum KölnCologne, GermanyNo longer taking part
- Universitätsklinikum Carl Gustav CarusDresden, GermanyNo longer taking part
- Universitätsklinikum DüsseldorfDüsseldorf, GermanyNo longer taking part
- Universitätsklinikum EssenEssen, GermanyNo longer taking part
- Universitatsklinikum LeipzigLeipzig, GermanyNo longer taking part
- Universitätsklinikum Schleswig-Holstein LübeckLübeck, GermanyNo longer taking part
- Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat HeidelbergMannheim, GermanyNo longer taking part
Trial details
- Who runs it
- Saving Patients' Lives Medical B.V.
- Trial code
- NCT04261777
- Record updated
- 28 April 2026
- Original description
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.Read full original descriptionShow less
A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).
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.
Inclusion: Voluntarily given and written informed consent; Male ≥18 years of age; Histologically newly-confirmed adenocarcinoma of the prostate; Medium to high risk for lymph node metastasis, defined by either:; PSA ≥10 ng/mL or; Gleason-Score ≥7 or; Stage cT2b or cT2c or T3 or T4; Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI; Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.
Exclusion: Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI; Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit; Known hypersensitivity to Ferrotran® or its components such as dextran; Known hypersensitivity to other parenteral iron products; Acute allergy, including drug allergies and allergic asthma; Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest); Patients with acute SARS-CoV-2 infection; Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant; Any contraindication to MRI, as per standard criteria; Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions); Presence of liver dysfunction; Simultaneous participation in any other clinical trial.