A clinical phase 3 study to assess the accuracy of Ferumoxtran-10 in Magnetic Resonance Imaging (MRI) to detect cancerous tissue in patients which are scheduled for a radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). All patients will receive the Ferumoxtran-10 and the imaging results will be compared with the analysis of the removed tissue samples.
- Conditions
- newly-diagnosed prostate cancer (PCA)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2018-004310-18-NL
- Lead Sponsor
- Saving Patients' Lives Medical B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 200
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method