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)

Phase 3

Recruiting

Conditions: Prostate Cancer
10027476

Registration Number: NL-OMON52732

Lead Sponsor: Saving Patients' Lives Medical B.V. (SPL Medical)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

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.

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The co-primary endpoints for this study will be the observed sensitivity (Se)<br /><br>and specificity (Sp) of the Ferrotran®-enhanced MRI compared with the<br /><br>unenhanced baseline MRI in assessing the nodal status (metastatic /<br /><br>non-metastatic) of the patient with respect to the lymph nodes considered for<br /><br>lymphadenectomy.<br /><br>Specificity and sensitivity of Ferrotran®-enhanced and un-enhanced MRI will be<br /><br>obtained by comparison of each method to histopathology results, and not by<br /><br>direct comparison of the MRI methods with each other.<br /><br>The patient will be considered metastatic (patientpositive) if at least one<br /><br>lymph node is diagnosed as metastatic in histopathology.</p><br>

Secondary Outcome Measures