PSMA 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.
TRUS 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.
Study 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.
Eligibility
Sex
MALE
Min age
30 Years
Max age
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
Primary outcome measure(s)
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).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Recruiting
More First Affiliated Hospital of Fujian Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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