Targeted plus perilesional biopsy versus targeted plus six‑core systematic biopsy to find prostate cancer
A Head-to-Head Comparison of Targeted and Perilesional Biopsy Versus Combination of Sextant-Systematic Biopsy and Targeted Biopsy for Prostate Cancer Diagnosis: A Randomized Controlled Trial
This study will test whether adding perilesional biopsy to MRI-targeted biopsy or combining targeted biopsy with a six‑core systematic biopsy better finds clinically significant prostate cancer in men with a single MRI-suspicious lesion who have not had a prior biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 592 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07460843 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial in biopsy‑naïve men with a single mpMRI-suspicious lesion (PI-RADS ≥3) randomly assigns participants to MRI-targeted plus perilesional biopsy (TB+PB) or MRI-targeted plus six‑core systematic biopsy (TB+6SB). Investigators will compare overall and clinically significant cancer detection rates, test non‑inferiority of TB+6SB versus TB+PB, and examine detection in the prostate lobe contralateral to the index lesion. Standardized mpMRI protocols and biopsy procedures are used to limit sampling variability, and outcomes include diagnostic yield, procedural complications, and biopsy burden. The trial is motivated by the penumbra concept that many clinically significant cancers lie close to MRI targets and that routine extended systematic sampling may be avoidable.
Who should consider this trial
Good fit: Men aged 18–85 who are biopsy‑naïve with a single mpMRI‑suspicious lesion (PI‑RADS ≥3), complete mpMRI data, and clinical indications for biopsy (e.g., elevated PSA or abnormal DRE) are eligible.
Not a fit: Patients with prior prostate biopsy, multiple or diffuse MRI lesions, unqualified or missing mpMRI, or other contraindications to prostate biopsy are unlikely to benefit from the specific biopsy schemes tested here.
Why it matters
Potential benefit: If successful, the approach could preserve or improve detection of clinically significant prostate cancer while reducing the number of biopsy cores, discomfort, and procedure‑related harms.
How similar studies have performed: Previous observational and single‑center studies supporting the penumbra concept suggest perilesional sampling can capture many clinically significant cancers, but direct randomized comparisons of TB+PB versus TB+6SB remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The age of the patient is between 18 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 \< 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.
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.