Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions

ConditionProstate Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-85

SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Targeted and perilesional biopsy (TPLBx)
Procedure/Surgery
The biopsy procedure is conducted by highly skilled and experienced urologists who specialize in performing prostate biopsies. A single dose of prophylactic antibiotics (usually cephalosporins) is routinely administered 30 min before the procedure. For each predefined MRI suspicious lesion, TBs are obtained within the ROI, followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depends on the shape and location of the suspicious lesion.
Combined targeted and systematic biopsy (CTSBx)
Procedure/Surgery
The biopsy procedure is conducted by highly skilled and experienced urologists who specialize in performing prostate biopsies. A single dose of prophylactic antibiotics (usually cephalosporins) is routinely administered 30 min before the procedure. TBs are performed within each predefined MRI suspicious lesion, followed by SB.

Treatment groups

572 Participants

are divided into 2 treatment groups

Group A: Targeted and perilesional biopsy (TPLBx)Experimental treatment 1 intervention

Group B: Combined targeted and systematic biopsy (CTSBx)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

The clinically significant prostate cancer (csPCa) detection rate for TPLBx and CTSBx schemes

The csPCa was defined as prostate cancer (PCa) with a grade group ≥2 or Gleason score (GS) ≥3+4. The reference standard was the pathological result.

Time frame