Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer (PRIDE2-PC)
Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：CONSTANTINOS ZAMBOGLOU, DR
- 电话号码：+35725208000
- 邮箱：kristis.vevis@goc.com.cy
学习地点
-
-
-
Limassol、塞浦路斯、4108
- 招聘中
- German Oncology Center
-
接触：
- CONSTANTINA CLOCONI
- 电话号码：+35725208000
- 邮箱：constantina.cloconi@goc.com.cy
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer
MRI-RSI imaging of the prostate (non-invasive)
|
MRI-RSI imaging of the prostate (non-invasive)
PET scan according to standard protocol
Biopsy according to standard protocol
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity
大体时间：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).
|
24 months
|
|
Absolute GTV volumes
大体时间：24 months
|
Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml
|
24 months
|
|
Specificity
大体时间：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).
|
24 months
|
|
ROC-AUC
大体时间：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
|
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dice Sorensen Coefficient (DSC)
大体时间：24 months
|
The DSC is defined as followed: twice the size of the intersection of two sets, divided by the sum of the sizes of the two sets.
The DSC will be used to compare different GTVs and likewise analyse the geometric overlap and the interobserver variance.
|
24 months
|
|
Dose volume histogram parameters in volume (ml) in relation to Gray
大体时间：24 months
|
Comparison of planning parameters and DVH metrics after PSMA PET and/or MRI-RSI based radiotherapy for target volumes and organs at risk.
|
24 months
|
|
Correlation coefficient (Spearman or Pearson)
大体时间：24 months
|
Quantitative imaging parameters from PSMA-PET, MRI-RSI and mpMRI images will be extracted and cross correlated with the ArteraAI MMAI test score (if available), Prolaris, the Ki-67 staining, the ISUP grade, serum PSA levels and the cTstage
|
24 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.