PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer Screening; PSMA-PET

• Registration Number: NCT06923657
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 230

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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%.
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).
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%.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China