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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group | Active Comparator | The control group will receive TRUS guided transperineal saturation biopsy. |
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| The experimental group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic 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. | 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. | 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%. | 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%. | 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%. | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| PRECISION Questionnaire | The incidence of complications for the two biopsy methods. | 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months. |
| EORTC QLQ-C30 Questionnaire |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Xu | Contact | 13235907575 | 0086 | drxun@fjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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|
| TRUS guided transperineal saturation biopsy | Diagnostic Test | The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis. |
|
| Perioperative |
| 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). | Perioperative |
The change in quality of life compared to baseline values in the experimental group and control group.
| 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. | 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. | Before diagnosis, 1 month, 3 months, 6 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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