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).
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 30
- 主要终点
- Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
研究概览
简要总结
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.
详细描述
Potential patients for this study will be recruited by up to 15 centres specialised in prostate cancer. Study sites will be interdisciplinary, consisting of a uro-oncology sub-site, and a radiology sub-site with high-quality MRI, surgery and pathology. Study visits will be typically conducted at the recruiting sub-site, or as institutionally appropriate. Treatment visits for patients will be performed in the collaborating sub-site. Patients will be invited for study participation by the investigators in the context of specialised clinics. Interested patients will be provided with an information sheet and will undergo a detailed informed consent procedure prior to any study procedures. Recruitment will be continued until a sufficient number of patients have undergone Ferrotran® imaging and histopathological evaluation.
To compensate for an expected drop-out rate of 15% to 20%, recruitment will only be stopped as soon as at least 69 evaluable positive (patients positive) and at least 104 evaluable negative (patients negative) patients are available for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
- •Simultaneous participation in any other clinical trial.
- •Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
- •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).
- •Patients with acute SARS-CoV-2 infection
研究组 & 干预措施
SPL-01-001
干预措施: Ferrotran® (Ferumoxtran-10) (Drug)
结局指标
主要结局
Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
时间窗: up to day 42
True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.
次要结局
- Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced).(up to day 105)
- Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI.(up to day 105)
- Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events)(day 0 - day 105)