Clinical trial NCT06923657: PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Official title: Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer Screening
PSMA-PET
Keywords: imaging examinations
PSMA PET/MRI
Prostate cancer
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 230
Sex: MALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 outcomes:
measure: Diagnostic Sensitivity
timeFrame: Perioperative
measure: Diagnostic Specificity
timeFrame: Perioperative
measure: Positive Predictive Value(PPV)
timeFrame: Perioperative
measure: Negative Predictive Value(NPV)
timeFrame: Perioperative
measure: Positive Likelihood Ratio(PLR)
timeFrame: Perioperative
measure: Negative Likelihood Ratio(NLR)
timeFrame: Perioperative
measure: Correct Diagnostic Index
timeFrame: Perioperative
Secondary outcomes:
measure: PRECISION Questionnaire
timeFrame: 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.
measure: EORTC QLQ-C30 Questionnaire
timeFrame: Before diagnosis, 1 month, 3 months, 6 months, 12 months
measure: Generalized Anxiety Disorder GAD-7 Scale
timeFrame: Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months
measure: Decision Conflict Scale, Decision Regret Scale
timeFrame: Before diagnosis, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: