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

May 26, 2026 updated by: Ning Xu, First Affiliated Hospital of Fujian Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The control group
The control group will receive TRUS guided transperineal saturation biopsy.
Diagnostic test: TRUS guided transperineal saturation biopsy
The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.
Experimental: The experimental group
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.
Diagnostic test: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
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. Clinical and pathological data of the patients will be collected for statistical analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Sensitivity
Time Frame: Perioperative
It refers to the percentage of patients who actually have prostate cancer correctly identified as positive (true positive). The calculation formula is: TP/(TP+FN)×100%. TP is true positive, and FN is false negative.
Perioperative
Diagnostic Specificity
Time Frame: Perioperative
It refers to the percentage of patients who do not actually have prostate cancer correctly identified as negative (true negative). The calculation formula is: TN/(TN+FP)×100%. TN is true negative, and FP is false positive.
Perioperative
Positive Predictive Value(PPV)
Time Frame: Perioperative
It refers to the proportion of true positives among the positive results obtained by a specific testing method. The calculation formula is: PPV = TP/(TP+FP)×100%.
Perioperative
Negative Predictive Value(NPV)
Time Frame: Perioperative
It refers to the proportion of true negatives among the negative results obtained by a specific testing method. The calculation formula is: NPV = TN/(TN+FN)×100%.
Perioperative
Positive Likelihood Ratio(PLR)
Time Frame: Perioperative
It refers to the ratio of the probability of correctly identifying a patient with prostate cancer as positive to the probability of incorrectly identifying a patient without prostate cancer as positive. The calculation formula is: +LR = Sensitivity / (1- Specificity)×100%.
Perioperative
Negative Likelihood Ratio(NLR)
Time Frame: Perioperative
It refers to the ratio of the probability of incorrectly identifying a patient with prostate cancer as negative to the probability of correctly identifying a patient without prostate cancer as negative. The calculation formula is:-LR = (1- Sensitivity) / Specificity×100%.
Perioperative
Correct Diagnostic Index
Time Frame: Perioperative
It refers to the sum of sensitivity and specificity minus 1. The correct diagnostic index can be used for comparing two diagnostic methods, with an ideal correct diagnostic index of 100%.r = (Specificity+Sensitivity) -1 = 1- (False Positive Rate + False Negative Rate).
Perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRECISION Questionnaire
Time Frame: 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.
The incidence of complications for the two biopsy methods.
1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.
EORTC QLQ-C30 Questionnaire
Time Frame: Before diagnosis, 1 month, 3 months, 6 months, 12 months
The change in quality of life compared to baseline values in the experimental group and control group.
Before diagnosis, 1 month, 3 months, 6 months, 12 months
Generalized Anxiety Disorder GAD-7 Scale
Time Frame: Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months
The difference in anxiety levels at each time point between the experimental group and the control group.
Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months
Decision Conflict Scale, Decision Regret Scale
Time Frame: Before diagnosis, 1 month, 3 months, 6 months
The decision-making differences at each time point between the experimental group and the control group.
Before diagnosis, 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH OfFMU[2024]837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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