Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
NCT Number: NCT06482645
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: PROCEDURE: Perilesional/regional systematic biopsy|PROCEDURE: Combination of systematic biopsy and targeted biopsy
Sponsor: Peking University First Hospital
Collaborators: Beijing Hospital|Shanghai East Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2026-06-30
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

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.

Primary Outcome Measures: The clinically significant prostate cancer (csPCa) detection rate for PB/RSB and TB+SB, csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological result., One month after the biopsy procedure.
Secondary Outcome Measures: The overall complication rate, The complication (mainly including bleeding, infection, pain, and lower urinary tract symptoms) rate after the prostate biopsy (PB/RSB or TB+SB)., One month after the biopsy procedure.|The self-reported quality of life after the prostate biopsy, The self-reported levels of pain and discomfort after the prostate biopsy was measured through visual analogue scale (VAS). The minimum and maximum values of VAS are 0 and 10. The higher VAS means the higher level of pain and discomfort., One month after the biopsy procedure.|The operation time of prostate biopsy, The operation time of prostate biopsy was defined as the time from the beginning to the end of the prostate biopsy., During the prostate biopsy procedure.|The PCa detection rate, The PCa detection rate for PB/RSB and combination of TB+SB., One month after the biopsy procedure.|The Gleason score (GS) of the biopsy sample, The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade., One month after the biopsy procedure.|The Gleason score (GS) of radical prostatectomy (RP) specimens, For the RP specimens, the Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade., One month after the biopsy procedure.