MRI With a Lymph Node Specific Contrast Agent: an Alternative for CT-Scanning and Lymph Node Dissection in Patients With Prostate Cancer?
试验速览
- 阶段
- 4 期
- 入组人数
- 396
- 试验地点
- 6
- 主要终点
- Primary outcome parameters concern accuracy sensitivity, specificity, PPV and NPV of both MRL and CT
研究概览
简要总结
This proposal is targeted at all patients with prostate cancer who are candidates for either curative surgery or curative radiotherapy in whom lymph node staging is indicated. Recently, it has been shown, that in patients with PSA <10 ng/ml and Gleason score < 7 the risk of lymph node metastases is low. Therefore, unnecessary PLND and non-invasive imaging can be avoided safely in this group. PLND is nowadays performed only in patients with intermediate or high risk for nodal metastases. Thus the subgroup of patients targeted in this study consists of patients with prostate cancer with a PSA >10 ng/ml and Gleason score > 6.
- If the high sensitivity (90%) and negative predictive value (96%) of MRL can be validated in the 8 participating centres, in patients with a negative MRL invasive PLND may be avoided.
- In patients with a positive MRL with enlarged nodes (larger than 8 mm) histological diagnosis may be obtained by imaged guided biopsy, and thus also in these patients avoid PLND. A limitation of image guide biopsy, however, is the 30% false negative rate. [Barentsz, Oyen, Wolf]
- In patients with positive small nodes (smaller than 8 mm) the urologist may, focussed by the MRL findings of a positive node outside his "surgical field-of-view", extend his dissection, and thus improve his accuracy.
- Based on the expected higher sensitivity of MRL this technique will completely replace CT-scanning.
详细描述
Objective(s) of the proposed study The first objective of this study is to evaluate whether MRL can replace currently used nodal staging techniques such as CT-scanning and PLND in patients with prostate cancer. The second objective is to determine the effects of implementing this new technique on diagnostic costs and the costs of therapeutic consequences. The third, methodological, objective is to develop a protocol for diagnostic test evaluation.
Define research questions of the proposed study
- Can the results -especially the high sensitivity (92%) and high negative predictive value (96%)- of a pilot study with a new nodal staging technique (MRL), be reproduced by other investigators?
- Can MRL improve the detection rate of small nodal metastases in normal sized nodes in patients with prostate cancer, compared to CT and lymph node dissection?
- Should MRL replace CT and PLND in the future, based on its high negative predictive value?
- Will replacement result in a decrease of the diagnostic costs and the costs of therapeutic consequences with equal quality of life using a time horizon of 6 months?
Study design (motivate) The design of the study to compare MRL versus CT and PLND to detect pelvic lymph node metastases in prostate cancer patients exists of two parts.
First to study the accuracy of the diagnostic options, consecutive patients will be subjected to both MRL and CT and further diagnostic and therapeutic action will depend on the absence or presence of lymph node metastases, irrespective of the test which indicated the metastases. Given the fact that both tests are performed in every participating patient and that both investigations will be made separately and read independently, a (randomised) comparative study is not needed. Because negative MRL will lead to PLND (based on pilot in 72% of the cases) and a positive MRL (28%) to biopsy, this observational study makes it possible to compare the MRL and CT results of all patients to the gold standard (histological findings). In the patients who will undergo PLND, the results of PLND can be compared directly to those of CT and MRL. As the imaging findings will guide the PLND, in these patients also the additional value of the diagnostic imaging techniques, e.g. removal of extra -image positive- nodes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •prostate cancer
- •PSA > 10 or Gleason > 6 or T3 tumor
- •adult male
- •scheduled for lymphadenectomy
- •written informed consent
排除标准
- •Patient having undergone chemotherapy or radiotherapy of the pelvic area
- •patient having undergone resection of the pelvic tumor with lymphadenectomy
- •Patient included in another trial involving an investigational drug
结局指标
主要结局
Primary outcome parameters concern accuracy sensitivity, specificity, PPV and NPV of both MRL and CT
次要结局
- Secondary outcome measures are costs per patient for each strategy. Besides this, quality of life after 6 months of follow up will be part of the analysis.