Eine klinische Studie der Phase 3 zur Beurteilung der Genauigkeit von Ferrotran in der Magnetresonanztomographie (MRI) zur Erkennung von Krebsgewebe bei Patienten, die für eine radikale Prostatektomie (RP) mit erweiterter Beckenlymphknotendissektion (ePLND) vorgesehen sind. Alle Patienten erhalten das Ferrotran und die Ergebnisse der Bildgebung werden mit der Analyse der entnommenen Gewebeproben verglichen.

Product Name: Ferumoxtran-10
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: FERUMOXTRAN-10
CAS Number: 189047-99-2
Current Sponsor code: Ferrotran?
Other descriptive name: FERUMOXTRAN-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105.2-

Gender:
Female: no
Male: yes

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:
a) PSA = 10 ng/ml or
b) Gleason-Score = 7 or
c) 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.
7)Preoperative PSA, clinical T-stage, primary Gleason grade, secondary Gleason grade.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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).