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

NCT06923657 | Recruiting

• 1 other identifier: MRCTA,ECFAH OfFMU[2024]837
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer Screening; PSMA-PET

Keywords

imaging examinations; PSMA PET/MRI; Prostate cancer

Outcome Measures

Primary Outcomes (7)

• Diagnostic Sensitivity

  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

  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)

  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)

  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)

  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)

  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

  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 Outcomes (4)

• PRECISION Questionnaire

  1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.

• EORTC QLQ-C30 Questionnaire

  Before diagnosis, 1 month, 3 months, 6 months, 12 months

• Generalized Anxiety Disorder GAD-7 Scale

  Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months

• Decision Conflict Scale, Decision Regret Scale

  Before diagnosis, 1 month, 3 months, 6 months

Study Arms (2)

The control group

ACTIVE COMPARATOR

The control group will receive TRUS guided transperineal saturation biopsy.

Diagnostic Test: TRUS guided transperineal saturation biopsy

The experimental group

EXPERIMENTAL

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

Interventions

PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy DIAGNOSTIC_TEST

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.

The experimental group

TRUS guided transperineal saturation biopsy DIAGNOSTIC_TEST

The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.

The control group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Ning Xu

CONTACT

13235907575; drxun@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 11, 2025
• Study Start: May 7, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)