Actively Recruiting

Age: 18Years +
MALE
ID06737588

The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer

Led by Anhui Provincial Hospital · Updated on 2025-02-11

600

Participants Needed

2

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how different Apparent Diffusion Coefficient (ADC) values from biparametric MRI (bpMRI) scans can improve the diagnosis of prostate cancer in patients with PI-RADS scores of 3 to 5. The study focuses on determining whether ADC values help better identify clinically significant prostate cancer (Gleason score 3+4 or higher, ISUP grade 2 or above) as well as any-grade prostate cancer (Gleason score 3+3 or higher, ISUP grade 1 or above). The study involves patients suspected of having prostate cancer who have undergone bpMRI and have PI-RADS scores between 3 and 5. Before prostate biopsy, researchers collect detailed information including age, BMI, PSA levels, prostate volume, ADC values, lesion size and location, among others. Prostate biopsy is then performed using systematic and possibly targeted methods, and pathological results serve as the gold standard for diagnosis. Diagnostic indicators such as ROC curves, sensitivity, specificity, and predictive values are calculated to compare how well different ADC values help diagnose prostate cancer. Participants provide clinical data and undergo standard bpMRI and biopsy procedures. Researchers analyze these results along with various diagnostic statistics and logistic regression to assess the value of ADC measurements in improving prostate cancer diagnosis. The primary outcome is to evaluate if ADC values enhance bpMRI's ability to detect clinically significant prostate cancer, with study completion expected around one month after enrollment. Secondary outcomes include assessing ADC's role in diagnosing any-grade prostate cancer and comparing diagnostic capacities based on PI-RADS scores combined with ADC cutoffs.

CONDITIONS

Brief Title

The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient meets at least one indication for prostate biopsy according to Chinese expert consensus (2022 edition)
  • Serum total PSA test completed with tPSA less than 100 ng/ml
  • Primary prostate tumor lesion present with no history of other tumors
  • Completed 3.0T biparametric MRI examination with PI-RADS score 3 or higher and clear readable images
  • Patients understand the study and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Contraindications for MRI
  • PI-RADS score of 1 or 2 on biparametric MRI
  • Contraindications to prostate biopsy or explicit refusal of biopsy
  • MRI indicates multiple lymph nodes or bone metastases
  • Previous prostate-related surgery
  • Refusal to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 month

Participants undergo biparametric MRI to assess PI-RADS scores and determine eligibility for prostate biopsy.

1 visit for bpMRI

Sample Collection

Duration - Within the diagnostic evaluation period

Participants who choose to undergo prostate biopsy have systematic and/or fusion targeted biopsies performed to obtain tissue samples for pathological analysis.

1 biopsy visit (in-person)

Long-term Monitoring

Duration - Up to 1 month

Researchers collect and analyze clinical and diagnostic data including ADC values and pathological results to evaluate diagnostic accuracy.

Data collection with no additional visits

Trial Site Locations

Total: 2 locations

1

Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

Hefei, Anhui, China, 230001

Actively Recruiting

2

Department of Urology, The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China, 241000

Not Yet Recruiting

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Research Team

C

Changming Wang

J

Jun Xiao

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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