Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions

NCT06841211 | Recruiting

• 1 other identifier: PB-03
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Randomized controlled trial; Targeted biopsy; Perilesional biopsy; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  One month after the biopsy procedure.

Secondary Outcomes (6)

• The PCa detection rate

  One month after the biopsy procedure.

• The clinically insignificant PCa (ciPCa) detection rate

  One month after the biopsy procedure.

• The higher-grade PCa detection rate for TPLBx and CTSBx schemes

  One month after the biopsy procedure.

• The Gleason score (GS) of the biopsy sample

  One month after the biopsy procedure.

• The GS of radical prostatectomy (RP) specimens

  One month after the RP.

Study Arms (2)

Targeted and perilesional biopsy (TPLBx)

EXPERIMENTAL

For patients in the TPLBx group, two-core targeted biopsies (TBs) were obtained within each predefined mpMRI suspicious lesion (region of interest, ROI), followed by ring-distributed four cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the ROI.

Procedure: Targeted and perilesional biopsy (TPLBx)

Combined targeted and systematic biopsy (CTSBx)

EXPERIMENTAL

For patients in the CTSBx group, two-core TBs from the lesion were performed within each ROI, followed by a sextant 12-core systematic biopsy (SB).

Procedure: Combined targeted and systematic biopsy (CTSBx)

Interventions

Targeted and perilesional biopsy (TPLBx) PROCEDURE

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 following a test dose 30 min before the procedure. Each patient is placed in the lithotomy position. Povidone-iodine is routinely used to clean perineum before the biopsy. The MRI-TRUS biopsy system is iFUSS (image fusion surgical system, Carbon Med), consisting of a 3D reconstruction and planning software (Carbon Med) and a bi-planar TRUS probe (ECL8-4-B, Carbon Med). Color Doppler examination is performed from the base to the apex. For each predefined mpMRI suspicious lesion, two-core TBs are obtained within the ROI, followed by ring-distributed four 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.

Targeted and perilesional biopsy (TPLBx)

Combined targeted and systematic biopsy (CTSBx) PROCEDURE

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 following a test dose 30 min before the procedure. Each patient is placed in the lithotomy position. Povidone-iodine is routinely used to clean perineum before the biopsy. The MRI-TRUS biopsy system is iFUSS (image fusion surgical system, Carbon Med), consisting of a 3D reconstruction and planning software (Carbon Med) and a bi-planar TRUS probe (ECL8-4-B, Carbon Med). Color Doppler examination is performed from the base to the apex. Two-core TBs from the lesion were performed within each predefined mpMRI suspicious lesion, followed by fore-zone 12-core biopsy.

Combined targeted and systematic biopsy (CTSBx)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi LIU

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi LIU

CONTACT

+86 13611035261; liuyipkuhsc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: February 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)