Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients (NCT04261777) | Clinical Trial Compass
TerminatedPhase 3
Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
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.
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
✕. 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.