Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients.
However, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and/or decrease the interobserver variability during tumor delineation.
This study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.
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
- •Newly diagnosed and histologically confirmed primary prostate cancer
- •NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk
- •Males, age ≥ 18 years
- •ECOG performance status 0-2
- •Estimated life expectancy ≥ 5 years
- •PSMA-PET/CT-hybrid imaging performed <3 months
- •MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed <6 months
排除标准
- •Contraindications for MRI imaging
- •No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion)
- •TUR-P of the prostate <1 year ago
- •Initial PSA >100 ng/ml
- •History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)
- •Previous radiation therapy to the pelvis
- •ADT or ADT + other systemic therapy before inclusion
研究组 & 干预措施
Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer
MRI-RSI imaging of the prostate (non-invasive)
干预措施: MRI (Diagnostic Test)
Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer
MRI-RSI imaging of the prostate (non-invasive)
干预措施: 18F-PSMA1007 PET-CT (Diagnostic Test)
Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer
MRI-RSI imaging of the prostate (non-invasive)
干预措施: MR-guided TRUS Prostate biopsy (Diagnostic Test)
结局指标
主要结局
Sensitivity
时间窗: 24 months
Sensitivity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true positives to the total number of segments with the disease (true positives + false negatives).
Absolute GTV volumes
时间窗: 24 months
Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml
Specificity
时间窗: 24 months
Specificity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true negatives to the total number of segments without the disease (true negatives + false positives).
ROC-AUC
时间窗: 24 months
ROC-AUC for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities on a segment level in comparison with prostate cancer distribution in targeted biopsy cores on a 6 segment level (ground truth). It will be calculated by integrating the area under the TPR (Sensitivity) vs FPR (1-Specificity) curve
次要结局
- Dice Sorensen Coefficient (DSC)(24 months)
- Dose volume histogram parameters in volume (ml) in relation to Gray(24 months)
- Correlation coefficient (Spearman or Pearson)(24 months)