Evaluating different biopsy methods for diagnosing prostate cancer

Efficacy and Safety Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial

This study is testing two different ways to take prostate biopsies to see which one finds cancer better and has fewer side effects for men who might have prostate cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 45 Years to 85 Years
• Sex: Male
• Sponsor: Peking University First Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06684652 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to assess the efficacy and safety of two prostate biopsy schemes: targeted biopsy plus sextant biopsy (3TB+6SB) and targeted biopsy combined with a 12-core systematic biopsy (3TB+12SB). The study will compare the cancer detection rates and complication rates associated with each method, focusing on the accurate diagnosis of clinically significant prostate cancer and the impact on postoperative quality of life. Participants will receive one of the two biopsy methods based on their eligibility criteria, which include age and specific imaging results.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 45 to 85 with a single suspicious lesion identified through mpMRI and no prior biopsy.

Not a fit: Patients with unqualified or incomplete mpMRI data or those who have previously undergone a biopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a safer and more effective method for diagnosing prostate cancer, potentially reducing complications and improving patient quality of life.

How similar studies have performed: While some retrospective studies suggest that the 3TB+6SB approach may be effective, this study is designed to provide high-quality, prospective evidence, making it a novel evaluation.

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.

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

Conditions: Prostate Cancer, Prostate cancer, Randomized controlled trial, Targeted biopsy, Systematic biopsy, Sextant biopsy