Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-85
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
Qualifiers
The age of the patient is between 45 and 85.
No previous biopsy.
Patients with single suspicious lesion, complete MRI 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.
Disqualifiers
The MRI data was unqualified or incomplete.
Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
Patients with previous biopsy.
Patients with PI-RADS V2.1 of < 4.
Trial design
Treatments tested in this trial
- TB+PB
- TB+SB
Treatment groups
640 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University First Hospital
Lead sponsor
Beijing Hospital
Collaborator
Shanghai East Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Chinese People's Liberation Army (PLA) General Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Source ClinicalTrials.gov