PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-85
SponsorFirst Affiliated Hospital of Fujian Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
Diagnostic testThe 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
Diagnostic testThe control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: The control groupActive comparator 1 intervention
Group B: The experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Perioperative2
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
Perioperative3
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
Perioperative4
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
PerioperativeSecondary outcomes
1
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.2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov