Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating different methods of taking biopsies to diagnose prostate cancer. Specifically, researchers want to see if a technique called perilesional/regional systematic biopsy (PB/RSB) is better at accurately detecting significant prostate cancer compared to a combination of targeted biopsy and systematic biopsy (TB+SB). They will also look at how safe these procedures are by checking for any complications and how they impact patients' quality of life after the biopsy.

To participate in this study, you need to be a man aged between 45 and 85 who has not had a previous biopsy. You should have a suspicious area in your prostate identified through imaging tests and meet specific criteria for a prostate biopsy. If you decide to join, you will receive one of the biopsy methods being studied. Researchers are currently looking for participants, so if you or someone you know fits the criteria, this could be an opportunity to contribute to important research on prostate cancer diagnosis.

Gender

MALE

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.