Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

NCT04261777 | Terminated Phase 3

• 1 other identifier: SPL-01-001
• Study Type: interventional
• Target: 172
• Locations: 4 countries
• Sites: 15

Brief 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.

Conditions

Prostate Cancer; Metastasis; Prostatectomy

Keywords

SPL-01-001; ePLND; MRI; USPIO; MR lymphography; Ferrotran; Ultra-small superparamagnetic iron oxide; Nanoparticles

Outcome Measures

Primary Outcomes (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.

  up to day 42

Secondary Outcomes (3)

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

  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)

  day 0 - day 105

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

  up to day 105

Study Arms (1)

SPL-01-001

EXPERIMENTAL

Drug: Ferrotran® (Ferumoxtran-10)

Interventions

Ferrotran® (Ferumoxtran-10) DRUG

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.

Also known as: Ferrotran Lyophilisate

SPL-01-001

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Saving Patients' Lives Medical B.V.: lead
• ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.: collaborator
• b.e.imaging GmbH: collaborator
• Radboud University Medical Center: collaborator

Study Sites (15)

Universitair Ziekenhuis Ghent

Ghent, 9000, Belgium

Location

Charité - Universitätsklinikum Berlin

Berlin, State of Berlin, 10117, Germany

Location

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Schleswig-Holstein Lübeck

Lübeck, 23538, Germany

Location

Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, 68167, Germany

Location

Nederlands Kanker Instituut Antoni van Leeuwenhoek

Amsterdam, 1006, Netherlands

Location

Radboud University Medical Center

Nijmegen, 6525, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis Nijmegen

Nijmegen, 6532, Netherlands

Location

Inselspital-Universitätsspital Bern

Bern, 3010, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 12815134 BACKGROUND

• 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.

  PMID: 18708295 BACKGROUND

• 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.

  PMID: 19401573 BACKGROUND

• 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.

  PMID: 9749478 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

ferumoxtran-10

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 10, 2020
• Study Start: May 27, 2020
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DE (10); NL (3); CH (1)