Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
Recruiting · NCT06482645 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University First Hospital
View the official record on ClinicalTrials.gov →Interventions studied
TB+PBTB+SB
What this trial is about
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.
Who can take part
Age range
45 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate MRI examination should not exceed one month.
- Patients with complete clinical information.
Exclusion criteria
- 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.
- 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.
Where it is running
1 location listed.
- Peking University First Hospital - Beijing, Beijing Municipality, China