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NCT Number: NCT06923657

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

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.

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Key information

Conditions

Prostate Cancer Screening Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site PSMA-PET Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location status: Recruiting

Location contact

Ning Xu

CONTACT

[email protected]

059187981687

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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%.

  4. 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%.

  5. 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%.

  6. 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%.

  7. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ning Xu

CONTACT

[email protected]

13235907575 ext. 0086

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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