Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions

Summary

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

Eligibility

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.

Conditions2

Browse More Trials