Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482645
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Efficacy and Safety Evaluation of PerilesionalRegional Systematic Biopsy in Diagnosis of Prostate Cancer a Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this multicenter randomized controlled trial RCT is to evaluate the efficacy and safety of different prostate biopsy schemes including perilesionalregional systematic biopsy PBRSB and combination of systematic biopsy and targeted biopsy TBSB
The main questions it aims to answer are
Does PBRSB promote the accurate diagnosis of clinically significant prostate cancer Whats the value of PBRSB in improving the safety of prostate biopsy Researchers will compare the cancer detection rates of PBRSB and combination of TBSB 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 PBRSB or TBSB
The main questions it aims to answer are
Does PBRSB promote the accurate diagnosis of clinically significant prostate cancer Whats the value of PBRSB in improving the safety of prostate biopsy Researchers will compare the cancer detection rates of PBRSB and combination of TBSB 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 PBRSB or TBSB
Detailed Description:
Currently combination of systematic biopsy and targeted biopsy TBSB 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 perilesionalregional systematic biopsy PBRSB 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 PBRSB schemes Thus this multicenter randomized controlled trial RCT aims to evaluate the efficacy and safety of PBRSB schemes and the routine TBSB schemes provide high-quality evidence for the optimization of prostate biopsy schemes
The main questions it aims to answer are
Does PBRSB promote the accurate diagnosis of clinically significant prostate cancer What is the value of PBRSB in improving the safety of prostate biopsy This prospective multi-institution RCT compared the csPCa detection rates of PBRSB and combination of TBSB 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 PBRSB group and TBSB group
Researchers will compare the cancer detection rates of PBRSB and combination of TBSB 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 PBRSB or TBSB
The main questions it aims to answer are
Does PBRSB promote the accurate diagnosis of clinically significant prostate cancer What is the value of PBRSB in improving the safety of prostate biopsy This prospective multi-institution RCT compared the csPCa detection rates of PBRSB and combination of TBSB 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 PBRSB group and TBSB group
Researchers will compare the cancer detection rates of PBRSB and combination of TBSB 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 PBRSB or TBSB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None