Clinical trial NCT06841211: Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions
Official title: Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions: a Randomized Controlled Trial Evaluating the Efficacy of Perilesional/Regional Biopsy in Prostate Cancer Diagnosis Among Men With Multiple mpMRI Visible Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Randomized controlled trial
Targeted biopsy
Perilesional biopsy
Diagnosis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: Prostate biopsies have been the cornerstone of prostate cancer (PCa) diagnosis, risk stratification, and treatment planning. The optimal biopsy scheme should achieve the highest csPCa detection rates with the most accurate core sites and the least biopsy-cores. The combined targeted and systematic biopsy (CTSBx) could effectively detect clinically significant PCa (csPCa) and was the standard scheme for patients with visible suspicious lesions on multiparametric MRI (mpMRI) in the past. However, some limitations existed in the CTSBx scheme, including the detection of clinically insignificant PCa (ciPCa), the risk of post-biopsy complications, and adverse pathological changes such as upgrade, upstage, capsule invasion, and positive surgical margin after the radical prostatectomy (RP). Therefore, more and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Recent studies demonstrated that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Focusing biopsy cores within and around the region of interest (ROI), known as targeted and perilesional biopsy (TPLBx) scheme, is recommended by the latest EAU guideline for the diagnosis of patients with visible suspicious lesions on multiparametric MRI (mpMRI).

Prostate cancer generally occurs multifocally. The incidence of multiple lesions among different cohorts in previous studies ranges between 20% and 50%. Though the CTSBx schemes are usually utilized for these patients, some previous studies suggested that additional systematic biopsy is of limited informative value in terms of overall csPCa detection. Therefore, the optimal prostate biopsy scheme for patients with multiple visible mpMRI suspicious lesions is still a matter of debate. Compared with the CTSBx scheme, the TPLBx changed the distribution of the biopsy-core according to the location of visible suspicious lesions. Many studies have preliminarily verified that the diagnostic efficacy of TPLBx was not inferior to that of CTSBx with the benefits of decreasing the detection of ciPCa and reducing biopsy cores. TPLBx scheme focuses biopsy cores within and around the ROI, which may evaluate the pathological characteristics of mpMRI visible suspicious lesions more accurately, benefiting for the treatment planning and reducing the occurrence rates of adverse pathological changes after the radical prostatectomy (RP). However, current data for TPLBx schemes are mostly retrospective, and few studies focused on the application of TPLBx for patients with multiple mpMRI visible lesions. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy of TPLBx and CTSBx schemes for patients with multiple mpMRI visible lesions, provide high-quality evidence for the optimization of prostate biopsy schemes.

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 criteria: 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.

Primary outcomes:
measure: The clinically significant prostate cancer (csPCa) detection rate for TPLBx and CTSBx schemes
timeFrame: One month after the biopsy procedure.
Secondary outcomes:
measure: The PCa detection rate
timeFrame: One month after the biopsy procedure.
measure: The clinically insignificant PCa (ciPCa) detection rate
timeFrame: One month after the biopsy procedure.
measure: The higher-grade PCa detection rate for TPLBx and CTSBx schemes
timeFrame: One month after the biopsy procedure.
measure: The Gleason score (GS) of the biopsy sample
timeFrame: One month after the biopsy procedure.
measure: The GS of radical prostatectomy (RP) specimens
timeFrame: One month after the RP.
measure: The adverse pathological outcomes of radical prostatectomy (RP) specimens
timeFrame: One month after the RP.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yi LIU
role: PRINCIPAL_INVESTIGATOR
References: