Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

NCT ID: NCT04261777

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-27
• Study Completion Date: 2025-01-15

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.

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.

Conditions

Prostate Cancer; Metastasis; Prostatectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SPL-01-001

Group Type: EXPERIMENTAL

Ferrotran® (Ferumoxtran-10)

Intervention Type: 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.

Interventions

Ferrotran® (Ferumoxtran-10)

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.

Intervention Type: DRUG

Other Intervention Names

Ferrotran Lyophilisate

Eligibility Criteria

Inclusion Criteria

1. Voluntarily given and written informed consent.

2. Male ≥18 years of age.

3. Histologically newly-confirmed adenocarcinoma of the prostate.

4. Medium to high risk for lymph node metastasis, defined by either:

1. PSA ≥10 ng/mL or

2. Gleason-Score ≥7 or

3. Stage cT2b or cT2c or T3 or T4

5. Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.

6. 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 Criteria

1. Any contraindication to MRI, as per standard criteria.

2. 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.

3. Known hypersensitivity to Ferrotran® or its components such as dextran.

4. Known hypersensitivity to other parenteral iron products.

5. Acute allergy, including drug allergies and allergic asthma.

6. Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).

7. Presence of liver dysfunction.

8. Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.

9. Simultaneous participation in any other clinical trial.

10. Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.

11. 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).

12. Patients with acute SARS-CoV-2 infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.

UNKNOWN

Sponsor Role: collaborator

b.e.imaging GmbH

UNKNOWN

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Saving Patients' Lives Medical B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Ghent

Ghent, , Belgium

Charité - Universitätsklinikum Berlin

Berlin, State of Berlin, Germany

Vivantes Klinikum Am Urban

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

Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, , Germany

Nederlands Kanker Instituut Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Radboud University Medical Center

Nijmegen, , Netherlands

Canisius-Wilhelmina Ziekenhuis Nijmegen

Nijmegen, , Netherlands

Inselspital-Universitätsspital Bern

Bern, , Switzerland

Countries

Belgium; Germany; Netherlands; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 12815134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18708295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19401573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9749478 (View on PubMed)

Other Identifiers

SPL-01-001

Identifier Type: -

Identifier Source: org_study_id