Prostate Cancer Screening, PSMA-PET
Conditions
Keywords
imaging examinations, PSMA PET/MRI, Prostate cancer
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
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.
DIAGNOSTIC_TESTTRUS guided transperineal saturation biopsy
The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Serum PSA \> 4 ng/mL * At least one prior negative prostate biopsy * At least two consecutive increases in PSA and/or PHI * Negative digital rectal examination * Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
Exclusion criteria
* Age ≤ 30 years or \> 85 years * Concurrent presence of other malignant tumors * Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy) * Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.) * Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.) * Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment) * Incomplete clinical or pathological data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity | Perioperative | 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. |
| Diagnostic Specificity | Perioperative | 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. |
| Positive Predictive Value(PPV) | Perioperative | 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%. |
| Negative Predictive Value(NPV) | Perioperative | 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%. |
| Positive Likelihood Ratio(PLR) | Perioperative | 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%. |
| Negative Likelihood Ratio(NLR) | Perioperative | 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%. |
| Correct Diagnostic Index | Perioperative | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRECISION Questionnaire | 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months. | The incidence of complications for the two biopsy methods. |
| EORTC QLQ-C30 Questionnaire | Before diagnosis, 1 month, 3 months, 6 months, 12 months | The change in quality of life compared to baseline values in the experimental group and control group. |
| Generalized Anxiety Disorder GAD-7 Scale | Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months | The difference in anxiety levels at each time point between the experimental group and the control group. |
| Decision Conflict Scale, Decision Regret Scale | Before diagnosis, 1 month, 3 months, 6 months | The decision-making differences at each time point between the experimental group and the control group. |
Countries
China
Contacts
CONTACTNing Xu
Outcome results
None listed