Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
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).
Sponsor: ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
Terminated
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.
A observational or N/A phase clinical study on Metastasis and Prostate Cancer, this trial is terminated or withdrawn. The trial is conducted by ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H. and has accumulated 17 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
17 versions recorded-
May 4, 2026 — Present [daily]
Terminated
Phase: PHASE3 → None
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Sep 2025 — May 2026 [monthly]
Terminated PHASE3
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Jun 2025 — Sep 2025 [monthly]
Terminated PHASE3
Status: Active Not Recruiting → Terminated
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Jan 2025 — Jun 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Sep 2024 — Jan 2025 [monthly]
Recruiting PHASE3
▶ Show 12 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jun 2024 — Jul 2024 [monthly]
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Jun 2023 — Jun 2024 [monthly]
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Sep 2022 — Jun 2023 [monthly]
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Mar 2022 — Sep 2022 [monthly]
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Feb 2022 — Mar 2022 [monthly]
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May 2021 — Jun 2021 [monthly]
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Jan 2021 — May 2021 [monthly]
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Dec 2020 — Jan 2021 [monthly]
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Jun 2020 — Dec 2020 [monthly]
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Mar 2020 — Jun 2020 [monthly]
Recruiting PHASE3
First recorded
Eligibility Summary
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.
Contact Information
- ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
- Radboud University Medical Center
- Saving Patients' Lives Medical B.V.
- b.e.imaging GmbH
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Amsterdam, Netherlands , Berlin, Germany , Berlin, Germany , Bern, Switzerland , Bonn, Germany , Cologne, Germany , Dresden, Germany , Düsseldorf, Germany , Essen, Germany , Ghent, Belgium and 5 more locations