Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different methods of taking prostate biopsies to improve the diagnosis of prostate cancer in men who have multiple visible lesions on an MRI scan. The trial aims to find out if a specific biopsy method that combines targeted and regional sampling (called TPLBx) is better at detecting significant prostate cancer compared to another method that combines systematic and targeted sampling (called CTSBx). This research is important because better biopsy techniques may help doctors make more accurate treatment plans and reduce the risk of complications during surgery.

To participate in the trial, men aged 18 to 85 who have not had a biopsy before and have multiple MRI-visible lesions may be eligible. Participants will be randomly assigned to receive either the TPLBx or CTSBx method. It’s important to note that certain health conditions may prevent someone from participating, such as having had previous cancer treatments or certain medical issues that affect biopsy safety. If eligible, participants can expect to undergo a prostate biopsy to help improve cancer detection and potentially lead to better outcomes in their treatment.

Gender

MALE

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.