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). - SPL-01-001

Saving Patients' Lives Medical B.V. (SPL Medical)0 个研究点目标入组 200 人开始时间: 2020年2月26日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•1. Any contraindication to MRI, as per standard criteria.
•2. Any radiation therapyor 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).
•12. Patients with acute SARS-CoV-2 infection

发起方

Saving Patients' Lives Medical B.V. (SPL Medical)