Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions
Recruiting · NCT06841211 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University First Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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 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.
Where it is running
1 location listed.
- Peking University First Hospital - Beijing, Beijing Municipality, China