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 range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
. 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.