Optimizing prostate biopsy techniques for men with multiple MRI-visible lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of different prostate biopsy methods in diagnosing prostate cancer in men with multiple visible lesions on multiparametric MRI (mpMRI). It compares two approaches: targeted and perilesional biopsy (TPLBx) versus combined targeted and systematic biopsy (CTSBx). The study aims to determine which method provides more accurate detection of clinically significant prostate cancer and reduces adverse outcomes after surgery. By focusing on the areas surrounding MRI-visible lesions, the trial seeks to improve diagnostic accuracy and treatment planning for patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* the age of the patient is between 18 and 85;
* no previous biopsy;
* presence of multiple MRI visible lesions;
* every MRI visible lesion is in accordance with the EAU guidelines for performing perilesional biopsy (PB) (PI-RADS ≥4 or PI-RADS =3, clinical suspicion of PCa);
* a verified prostate-specific antigen (PSA) less than 50 ng/ml;
* complete MRI data, and high MRI quality (Prostate Imaging Quality \[PI-QUAL\] V1.0 score ≥3);
* the time interval between prostate biopsy and prostate MRI examination should not exceed one month;
* patients with complete prostate biopsy pathological results;
* patients with complete clinical information.

Exclusion Criteria:

* contraindication for MRI examination (i.e., in acute attack period such as high fever, coma, epilepsy, prone to cardiac arrest, claustrophobia, presence of ferrous metallic implants, or claustrophobia);
* contraindication for prostate biopsy ((a) in the period of acute infection or fever; (b) hypertensive crisis; (c) in the decompensated stage of heart failure; (d) diseases with severe bleeding tendency; (e) poorly controlled complications of hypertension or diabetes; (f) patients with severe internal or external hemorrhoids, perianal or rectal lesions should not undergo transrectal biopsy);
* a history of radiotherapy, chemotherapy, androgen deprivation therapy, or surgery for PCa;
* patients with previous biopsy;
* the absence of MRI-visible prostate lesions or presence of single suspicious lesions;
* PI-RADS V2.1 \<3;
* unqualified or incomplete MRI data;
* the patient could not cooperate to complete the prostate biopsy;
* the patients or their family members refused to participate in this study;
* patients with incomplete clinical information.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yi LIU — Peking University First Hospital
• Study coordinator: Yi LIU
• Email: liuyipkuhsc@163.com
• Phone: +86 13611035261

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.