PSMA PET/MRI-guided prostate biopsy for men with prior negative biopsies and low PI-RADS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Observational study on Lutetium-177 treatment for metastatic prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.