Clinical trial NCT06482645: Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
Official title: Efficacy and Safety Evaluation of Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Multicenter randomized controlled trial
Perilesional biopsy
Regional systematic biopsy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Shanghai East Hospital
First posted: 2024-07-01
Enrollment: 300
Sex: MALE
Minimum age (years): 45
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 multicenter randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including perilesional/regional systematic biopsy (PB/RSB) and combination of systematic biopsy and targeted biopsy (TB+SB).

The main questions it aims to answer are:

Does PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB/RSB and combination of TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.

Participants will:

Receive PB/RSB or TB+SB.

Detailed description: Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the combined biopsy approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the PB/RSB schemes. Thus, this multicenter randomized controlled trial (RCT) aims to evaluate the efficacy and safety of PB/RSB schemes and the routine TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.

The main questions it aims to answer are:

Does PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What is the value of PB/RSB in improving the safety of prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of PB/RSB and combination of TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China), Beijing Hospital (Beijing, China), and Shanghai East Hospital (Shanghai, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group.

Researchers will compare the cancer detection rates of PB/RSB and combination of TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.

Participants will:

Receive PB/RSB or TB+SB.

Eligibility criteria: Inclusion Criteria:

* The age of the patient is between 45 and 85.
* No previous biopsy.
* Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of \> 3.
* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
* The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.
* Patients with complete clinical information.

Exclusion Criteria:

* The mpMRI data was unqualified or incomplete.
* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
* Patients with previous biopsy.
* Patients with PI-RADS V2.1 of \< 4.
* Patients were not in accordance with the indication of prostate biopsy.
* 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 PB/RSB and TB+SB
timeFrame: One month after the biopsy procedure.
Secondary outcomes:
measure: The overall complication rate
timeFrame: One month after the biopsy procedure.
measure: The self-reported quality of life after the prostate biopsy
timeFrame: One month after the biopsy procedure.
measure: The operation time of prostate biopsy
timeFrame: During the prostate biopsy procedure.
measure: The PCa detection rate
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 Gleason score (GS) of radical prostatectomy (RP) specimens
timeFrame: One month after the biopsy procedure.
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: