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

Fujian Medical University (FJMU)

Status: Enrolling

Conditions: Prostate Cancer Screening; PSMA-PET

Treatments: Diagnostic Test: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy; Diagnostic Test: TRUS guided transperineal saturation biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06923657

MRCTA,ECFAH OfFMU[2024]837

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: Male

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

The control group

Active Comparator group

Description:

The control group will receive TRUS guided transperineal saturation biopsy.

Treatment:

Diagnostic Test: TRUS guided transperineal saturation biopsy

The experimental group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy