On November 14, a research team led by Prof. Kan Gong and Associate Chief Physician Yi Liu from the Department of Urology, Peking University First Hospital and the Institute of Urology, Peking University, published a major advancement in precision prostate biopsy in eClinicalMedicine, a sub-journal of The Lancet. 

The study brings encouraging news: for patients undergoing precision biopsy for suspected prostate cancer, reducing the standard 12-core systematic biopsy to 6 cores does not compromise diagnostic accuracy. This means clinicians can maintain high cancer detection rates while significantly reducing needle punctures—lowering bleeding and infection risks, improving comfort, accelerating recovery, and enhancing clinical efficiency.

Urgent Need for Precision Diagnosis: Traditional Biopsy Requires Optimization

Prostate cancer is the second most common malignancy among men worldwide and ranks first among genitourinary tumors in China. Due to low screening rates, 65% of Chinese patients are diagnosed at a locally advanced or metastatic stage, and the overall 5-year survival rate remains only ~67%, far below the >97% seen in developed countries. Improving early, accurate diagnosis is critically important.

Prostate biopsy is the gold standard for diagnosis. Current guidelines recommend MRI-targeted biopsy combined with 12-core systematic biopsy for first-time biopsy in patients with PIRADS ≥3 lesions.

However, with modern MRI technology, most clinically significant tumors can already be detected by targeted biopsy alone. The traditional 12- or even 24-core systematic biopsy contributes diminishing diagnostic benefit, while increasing risks such as:

• pain and bleeding

• urinary retention

• infectious complications

• overtreatment

• longer procedure time and higher costs

This raises a crucial clinical question: Can the number of biopsy cores be reduced to improve safety and comfort without compromising diagnostic accuracy?

Until now, high-quality prospective evidence supporting such optimization has been scarce worldwide.

Peking University Team Leads Innovation: First RCT Demonstrating Feasibility of a “Reduced-Core” Biopsy Strategy

The Peking University Urology team conducted a head-to-head, non-inferiority randomized controlled trial (RCT) enrolling 506 patients with a single unilateral MRI-visible lesion undergoing initial biopsy. The study compared:

• Targeted biopsy + 6-core systematic biopsy (TB+6SB) versus

• Targeted biopsy + 12-core systematic biopsy (TB+12SB, standard of care)

Key Findings: Both strategies achieved nearly identical detection rates for clinically significant prostate cancer (csPCa):

• 54.3% (138/254) in TB+6SB

• 54.8% (138/252) in TB+12SB

Rates of high-grade cancer detection and concordance between biopsy and prostatectomy pathology were also comparable.

Importantly, the reduced-core strategy:

• shortened procedure time

• reduced pain and discomfort

• lowered complication risk

• decreased overall cost

• improved the patient experience

This RCT provides strong evidence that in the modern MRI-targeted biopsy era, systematic biopsy can be streamlined without sacrificing diagnostic performance.

Driving Innovation: Upgrading Precision Prostate Cancer Diagnosis in China

This study is the world’s first RCT validating a modified six-zone reduced-core prostate biopsy strategy. It provides high-level evidence supporting optimization of prostate cancer biopsy practice.

The team plans to collaborate across multiple centers to conduct larger trials, promote the innovative Peking University biopsy strategy nationwide, and further advance precision diagnosis—benefiting more patients through more accurate, safer, and more comfortable biopsy procedures.

Corresponding and First Authors

Corresponding Authors

• Prof. Kan Gong

• Associate Chief Physician Yi Liu

Co–First Authors

• Dr. Ruiyi Deng

• Dr. Jiaheng Shang