NCT06841211Recruiting

Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions

Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions: a Randomized Controlled Trial Evaluating the Efficacy of Perilesional Biopsy in Prostate Cancer Diagnosis

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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 MRI visible lesions, including combination of targeted and perilesional (PB) (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 MRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple MRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, and capsule invasion among patients with multiple MRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes. Participants will: Receive TPLBx or CTSBx.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 572 (estimated)
First submitted: 18 Feb 2025
Start date: 1 Feb 2025
Primary completion date: 31 Aug 2026
Lead sponsor: Peking University First Hospital
Diseases: Prostate cancer
NCT number: NCT06841211

What you commit to

Study type: Interventional
Planned participants: 572
From 1 Feb 2025 to the primary completion date, 31 Aug 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

patients with previous biopsy;

Other illness

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;

Other

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.

Who the study is looking for

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.

Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Peking University First Hospital Coordinator of this site? Confirm its status	Beijing	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.