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

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

This study is testing two different ways to do prostate biopsies in men with multiple visible lesions on MRI to see which method finds prostate cancer more accurately and safely.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Peking University First Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06841211 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 to 85 with multiple mpMRI visible lesions and no prior biopsy.

Not a fit: Patients with contraindications for mpMRI or prostate biopsy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate prostate cancer diagnoses and better treatment outcomes for patients.

How similar studies have performed: Previous studies have shown promise in optimizing biopsy techniques, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

* the age of the patient is between 18 and 85;
* no previous biopsy;
* presence of multiple multiparametric magnetic resonance imaging (mpMRI) visible lesions;
* every mpMRI 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 mpMRI data, and high mpMRI quality (Prostate Imaging Quality \[PI-QUAL\] V1.0 score ≥3);
* the time interval between prostate biopsy and prostate mpMRI examination should not exceed one month;
* patients with complete prostate biopsy pathological results;
* patients with complete clinical information.

Exclusion Criteria:

* contraindication for mpMRI 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 mpMRI 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 this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Yi LIU — Peking University First Hospital
• Study coordinator: Yi LIU

Conditions: Prostate Cancer, Prostate cancer, Randomized controlled trial, Targeted biopsy, Perilesional biopsy, Diagnosis