Evaluating a new biopsy method for diagnosing prostate cancer
Efficacy and Safety Evaluation of Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial
This study is testing a new way to take prostate biopsies to see if it can find cancer more accurately and safely than the current methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | Male |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06482645 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to assess the efficacy and safety of perilesional/regional systematic biopsy (PB/RSB) compared to the combination of systematic biopsy and targeted biopsy (TB+SB) for diagnosing clinically significant prostate cancer. The study will analyze cancer detection rates and complication rates associated with each biopsy method, as well as the impact on postoperative quality of life. Participants will receive either PB/RSB or TB+SB based on their eligibility criteria, which include age and specific imaging results. The trial seeks to provide high-quality evidence regarding the optimization of prostate biopsy techniques.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 to 85 with a single suspicious lesion and specific imaging results indicating the need for a prostate biopsy.
Not a fit: Patients who have had a previous biopsy or whose mpMRI data is unqualified or incomplete may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more accurate method for diagnosing prostate cancer, potentially reducing complications and improving patient quality of life.
How similar studies have performed: Previous studies have shown promising results for similar biopsy approaches, but this trial aims to provide high-quality, prospective evidence for the PB/RSB method.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yi LIU — Peking University First Hospital
- Study coordinator: Yi LIU
- Email: liuyipkuhsc@163.com
- Phone: +86 13611035261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.