Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
MALE
NCT06841211

Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions

Led by Peking University First Hospital · Updated on 2025-02-25

400

Participants Needed

1

Research Sites

64 weeks

Total Duration

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AI-Summary

What this Trial Is About

The goal of this randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes in prostate cancer diagnosis among men with multiple mpMRI visible lesions, including combination of targeted and perilesional/regional biopsy (PB/RB) (TPLBx) and combination of systematic biopsy and targeted biopsy (CTSBx). The main questions it aims to answer are: Does TPLBx promote the accurate diagnosis of clinically significant prostate cancer (csPCa) among men with multiple mpMRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple mpMRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, capsule invasion, and positive surgical margin among patients with multiple mpMRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes. They will evaluate the occurrence rates of adverse pathological changes of different prostate biopsy schemes after the radical prostatectomy (RP). Participants will: Receive TPLBx or CTSBx.

CONDITIONS

Official Title

Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions

Who Can Participate

Age: 18Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • No previous prostate biopsy
  • Presence of multiple visible lesions on multiparametric MRI (mpMRI)
  • Each lesion meets EAU guidelines for perilesional biopsy (PI-RADS 4 or higher, or PI-RADS 3 with clinical suspicion)
  • Prostate-specific antigen (PSA) level less than 50 ng/ml
  • Complete and high-quality mpMRI data (PI-QUAL score 3 or higher)
  • Time between prostate biopsy and mpMRI no longer than one month
  • Complete prostate biopsy pathological results
  • Complete clinical information
Not Eligible

You will not qualify if you...

  • Contraindications for mpMRI (such as acute illness, fever, coma, epilepsy, risk of cardiac arrest, claustrophobia, or ferrous metallic implants)
  • Contraindications for prostate biopsy (acute infection or fever, hypertensive crisis, advanced heart failure, severe bleeding disorders, poorly controlled hypertension or diabetes, severe hemorrhoids or rectal lesions)
  • History of radiotherapy, chemotherapy, androgen deprivation therapy, or prostate cancer surgery
  • Previous prostate biopsy
  • No visible lesions or only a single suspicious lesion on MRI
  • PI-RADS score less than 3
  • Unqualified or incomplete mpMRI data
  • Unable to cooperate for prostate biopsy
  • Refusal to participate by patient or family
  • Incomplete clinical information

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

Y

Yi LIU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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