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
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.
• 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.