Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 15 May 2023
• Main ID: NCT04261777
• Date of registration: 27/01/2020
• Prospective Registration: Yes
• Primary sponsor: Saving Patients' Lives Medical B.V.
• Public title: Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
• Scientific 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).
• Date of first enrolment: May 27, 2020
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04261777
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Germany, Netherlands, Switzerland

Contacts

• Name: Jürgen Feuerstein, Dr.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatectomy

Metastasis

Prostate Cancer

Intervention(s)

Drug: Ferrotran® (Ferumoxtran-10)

Primary Outcome(s)

Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced). [Time Frame: up to day 42]

Secondary Outcome(s)

Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI. [Time Frame: 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) [Time Frame: day 0 - day 105]

Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced). [Time Frame: up to day 105]

Secondary ID(s)

SPL-01-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Radboud University Medical Center

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

b.e.imaging GmbH