Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- optimal combination of quantitative MRI parameters that best correlates to the presence of (lymph node) metastases in prostate cancer as seen on PSMA-PET/CT.
研究概览
简要总结
The primary aim of this study is to assess the potential of quantitative MRI measurements to predict localized prostate cancer T-stage and disease spread to nodes (N-stage) by correlating quantitative MRI measurements of the local prostate to the presence of metastases as seen on PSMA-PET/CT.
详细描述
Patients diagnosed with prostate cancer will likely not die from the primary tumor, but from (extended) metastatic disease. One of the first steps towards extended metastatic disease is the presence of lymph node metastases, which is an important factor in determining therapy and prognosis. Although historically all patients with lymph node metastases are considered incurable, research has shown that patients with only a limited number of small (<8 mm) nodal metastases have a better prognosis as compared to patients with more extensive involvement. In patients with only a limited number of small nodal metastases (oligo-metastatic), therapy with curative intent might be pursued, e.g. by surgical resection or loco-regional radiotherapy. With continuously improving opportunities to very selectively treat small numbers of metastatic sites it is of utmost importance to accurately diagnose the first signs of oligo-metastatic disease and to define its extent.
It is hypothesized that magnetic resonance imaging (MRI) can obtain more information from the local prostate than what is now used in the clinic to stage localized prostate cancer and oligo-metastatic disease. In recent years positron emission tomography (PET) in combination with computerized tomography (CT) and Prostate Specific Membrane Antigen (PSMA) tracers (PSMA-PET/CT) has emerged as an imaging modality to visualize (early) metastatic disease, but its accuracy in detecting oligo-metastatic spread is unknown, as small nodal metastases can be missed. In this study, the correlation is assessed between functional, quantitative and metabolic local tumor characteristics with PSMA-PET/CT-proven nodal involvement, to be able to predict metastatic potential from quantitative MRI parameters of the localized tumor. If the study shows potential for predicting presence of metastatic disease, future patients will benefit from improved nodal staging, potentially leading to more accurate and personalized treatment of the correct disease stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary cancer of the prostate, based on prostate biopsy-core analysis.
- •Patient is scheduled and fit for PSMA-PET/CT
- •Age≥50 years. Ability to give voluntary written informed consent to participate in this study.
排除标准
- •Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
- •Prior prostate cancer treatment.
- •Prior pelvic surgery, associated with pelvic lymphadenopathy
- •Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial.
- •Inability to lie still for 45 minutes or comply with imaging.
- •The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.
结局指标
主要结局
optimal combination of quantitative MRI parameters that best correlates to the presence of (lymph node) metastases in prostate cancer as seen on PSMA-PET/CT.
时间窗: within 14 days of PSMA-PET/CT scan, before any therapy
To find the optimal combination of quantitative parameters for discriminating between positive and negative PSMA-PET/CT, logistic regression modelling will be used. The performance of the model will be evaluated using receiver operating characteristic curve analysis.
次要结局
- MR parameters that correlate to the amount of metastases as found on PSMA-PET/CT(within 14 days of PSMA-PET/CT scan, before any therapy)
- MR parameters that correlate to local prostate PSMA-PET intensity(within 14 days of PSMA-PET/CT scan, before any therapy)
- the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease(within 14 days of PSMA-PET/CT scan, before any therapy)