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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
MRI-RSI imaging of the prostate (non-invasive)
PET scan according to standard protocol
Biopsy according to standard protocol
German Oncology Center
Limassol, Cyprus
RECRUITINGSensitivity
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).
Time frame: 24 months
Absolute GTV volumes
Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml
Time frame: 24 months
Specificity
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).
Time frame: 24 months
ROC-AUC
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
Time frame: 24 months
Dice Sorensen Coefficient (DSC)
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.
Time frame: 24 months
Dose volume histogram parameters in volume (ml) in relation to Gray
Comparison of planning parameters and DVH metrics after PSMA PET and/or MRI-RSI based radiotherapy for target volumes and organs at risk.
Time frame: 24 months
Correlation coefficient (Spearman or Pearson)
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
Time frame: 24 months
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