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Prostate CancerPhase 3NCT04261777

Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

A Phase 3 study testing Ferrotran® (Ferumoxtran-10) in people with Prostate Cancer and Metastasis, run by Saving Patients' Lives Medical B.V. at 15 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Metastasis, Prostatectomy
What is being tested?
Ferrotran® (Ferumoxtran-10)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
15 sitesin 4 countries
Study dates
27 May 2020to 15 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • Any contraindication to MRI, as per standard criteria.
  • 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.
  • 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.
  • Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
Show all 12Show fewer
  • Presence of liver dysfunction.
  • Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
  • Simultaneous participation in any other clinical trial.
  • Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
  • 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

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

Germany10 sites

  • Charité - Universitätsklinikum Berlin

    Berlin, State of Berlin, 10117

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Schleswig-Holstein Lübeck

    Lübeck, 23538

  • Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

Other trials in Germany

Netherlands3 sites

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek

    Amsterdam, 1006

  • Radboud University Medical Center

    Nijmegen, 6525

  • Canisius-Wilhelmina Ziekenhuis Nijmegen

    Nijmegen, 6532

Other trials in Netherlands

Belgium1 site

  • Universitair Ziekenhuis Ghent

    Ghent, 9000

Other trials in Belgium

Switzerland1 site

  • Inselspital-Universitätsspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Ferrotran® (Ferumoxtran-10)
Keywords
SPL-01-001, ePLND, MRI, USPIO, MR lymphography, Ferrotran, Ultra-small superparamagnetic iron oxide, Nanoparticles
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferrotran® (Ferumoxtran-10)Drug

    Also called Ferrotran Lyophilisate

    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.

Study groups in NCT04261777
Study groupRoleWhat they receive
SPL-01-001ExperimentalNot described
Receives: Drug: Ferrotran® (Ferumoxtran-10)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to day 42

Secondary outcomes (3)

  1. Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced).

    Measured: up to day 105

  2. Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events)

    Measured: day 0 - day 105

  3. Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI.

    Measured: up to day 105

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start27 May 2020
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261777
Sponsor's protocol ID
SPL-01-001
Status last verified
Apr 2026
First submitted
27 Jan 2020
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harisinghani MG, Barentsz J, Hahn PF, Deserno WM, Tabatabaei S, van de Kaa CH, de la Rosette J, Weissleder R. Noninvasive detection of clinically occult lymph-node metastases in prostate cancer. N Engl J Med. 2003 Jun 19;348(25):2491-9. doi: 10.1056/NEJMoa022749.

    PubMed 12815134

  • Heesakkers RA, Hovels AM, Jager GJ, van den Bosch HC, Witjes JA, Raat HP, Severens JL, Adang EM, van der Kaa CH, Futterer JJ, Barentsz J. MRI with a lymph-node-specific contrast agent as an alternative to CT scan and lymph-node dissection in patients with prostate cancer: a prospective multicohort study. Lancet Oncol. 2008 Sep;9(9):850-6. doi: 10.1016/S1470-2045(08)70203-1. Epub 2008 Aug 15.

    PubMed 18708295

  • Heesakkers RA, Jager GJ, Hovels AM, de Hoop B, van den Bosch HC, Raat F, Witjes JA, Mulders PF, van der Kaa CH, Barentsz JO. Prostate cancer: detection of lymph node metastases outside the routine surgical area with ferumoxtran-10-enhanced MR imaging. Radiology. 2009 May;251(2):408-14. doi: 10.1148/radiol.2512071018.

    PubMed 19401573

  • D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.

    PubMed 9749478

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferrotran® (Ferumoxtran-10) in people with Prostate Cancer and Metastasis, run by Saving Patients' Lives Medical B.V. at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, Netherlands, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced). (time frame: up to day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04261777, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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