PSMA PET/MRI-guided prostate biopsy for men with prior negative biopsies and low PI-RADS
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
This trial will try whether PSMA PET/MRI-guided targeted biopsies find more clinically significant prostate cancer than standard TRUS transperineal saturation biopsies in men with prior negative biopsies, rising PSA or PHI, and PI-RADS ≤3.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06923657 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized comparison enrolling men with prior negative prostate biopsies, persistent PSA or PHI elevation, negative DRE, and mpMRI showing PI-RADS ≤3. Participants are randomized to PSMA PET/MRI with TRUS-guided targeted plus saturation biopsy versus standard TRUS-guided transperineal saturation biopsy. The primary outcome is the detection rate of clinically significant prostate cancer (csPCa) between the two arms. The study aims to determine if adding PSMA PET/MRI guidance reduces missed csPCa and optimizes diagnostic workflow for this challenging subgroup.
Who should consider this trial
Good fit: Men older than 30 and younger than 85 with serum PSA > 4 ng/mL, at least one prior negative prostate biopsy, at least two consecutive rises in PSA and/or PHI, negative DRE, and mpMRI PI-RADS ≤3 are ideal candidates.
Not a fit: Patients with other active malignancies, prior prostate surgery or anti-tumor therapy, contraindications to PSMA PET/MRI or prostate biopsy, severe organ dysfunction, or incomplete clinical data are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, PSMA PET/MRI guidance could increase detection of clinically significant prostate cancer and reduce missed diagnoses and unnecessary repeat biopsies for men with prior negative biopsies.
How similar studies have performed: PSMA-targeted imaging and PSMA-guided biopsies have shown promising detection improvements in prior work, but the specific use of PSMA PET/MRI for men with PI-RADS ≤3 and prior negative biopsies remains relatively novel and less extensively validated.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Ning Xu
- Email: drxun@fjmu.edu.cn
- Phone: 13235907575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.