Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Nov 10, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two different methods for taking prostate biopsies to see which one is better at detecting prostate cancer. The trial compares a combination of targeted biopsy (focusing on areas that look suspicious) with either a smaller number of standard biopsies (3TB+6SB) or a larger number of standard biopsies (3TB+12SB). The researchers want to find out if the first method is more accurate and safer for men who may have prostate cancer.

To participate in this study, men aged between 45 and 85 who have not had a previous biopsy and have specific suspicious lesions identified through imaging tests may be eligible. Participants will receive one of the biopsy methods, and their experiences will be monitored for safety and recovery after the procedure. This trial is currently recruiting participants, and it aims to improve prostate cancer diagnosis while ensuring patients' safety and quality of life during the process.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • The age of the patient is between 45 and 85 years.
• • 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 \< 3.
• • 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.