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
Qualifiers
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
Treatments tested in this trial
- PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
- TRUS guided transperineal saturation biopsy
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov