NCT06923657Recruiting
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 7 May 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT06923657
What you commit to
- Study type: Interventional
- Planned participants: 230
- From 7 May 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent presence of other malignant tumors
- Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
Other illness
- 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)
Age
- Age ≤ 30 years or \> 85 years
Other
- Incomplete clinical or pathological data
Who the study is looking for
- 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
Age in the registry: 30 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.