The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.
This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
230
The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. Clinical and pathological data of the patients will be collected for statistical analysis.
The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGDiagnostic Sensitivity
It refers to the percentage of patients who actually have prostate cancer correctly identified as positive (true positive). The calculation formula is: TP/(TP+FN)×100%. TP is true positive, and FN is false negative.
Time frame: Perioperative
Diagnostic Specificity
It refers to the percentage of patients who do not actually have prostate cancer correctly identified as negative (true negative). The calculation formula is: TN/(TN+FP)×100%. TN is true negative, and FP is false positive.
Time frame: Perioperative
Positive Predictive Value(PPV)
It refers to the proportion of true positives among the positive results obtained by a specific testing method. The calculation formula is: PPV = TP/(TP+FP)×100%.
Time frame: Perioperative
Negative Predictive Value(NPV)
It refers to the proportion of true negatives among the negative results obtained by a specific testing method. The calculation formula is: NPV = TN/(TN+FN)×100%.
Time frame: Perioperative
Positive Likelihood Ratio(PLR)
It refers to the ratio of the probability of correctly identifying a patient with prostate cancer as positive to the probability of incorrectly identifying a patient without prostate cancer as positive. The calculation formula is: +LR = Sensitivity / (1- Specificity)×100%.
Time frame: Perioperative
Negative Likelihood Ratio(NLR)
It refers to the ratio of the probability of incorrectly identifying a patient with prostate cancer as negative to the probability of correctly identifying a patient without prostate cancer as negative. The calculation formula is:-LR = (1- Sensitivity) / Specificity×100%.
Time frame: Perioperative
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Correct Diagnostic Index
It refers to the sum of sensitivity and specificity minus 1. The correct diagnostic index can be used for comparing two diagnostic methods, with an ideal correct diagnostic index of 100%.r = (Specificity+Sensitivity) -1 = 1- (False Positive Rate + False Negative Rate).
Time frame: Perioperative
PRECISION Questionnaire
The incidence of complications for the two biopsy methods.
Time frame: 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.
EORTC QLQ-C30 Questionnaire
The change in quality of life compared to baseline values in the experimental group and control group.
Time frame: Before diagnosis, 1 month, 3 months, 6 months, 12 months
Generalized Anxiety Disorder GAD-7 Scale
The difference in anxiety levels at each time point between the experimental group and the control group.
Time frame: Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months
Decision Conflict Scale, Decision Regret Scale
The decision-making differences at each time point between the experimental group and the control group.
Time frame: Before diagnosis, 1 month, 3 months, 6 months