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Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
Sponsor: Peking University First Hospital
Summary
The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes. Participants will: Receive TB+PB or TB+SB.
Official title: Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
45 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2024-07-01
Completion Date
2026-12-31
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
TB+PB
The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.
TB+SB
The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB.
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China