Targeted and Perilesional or Systematic Biopsies in Prostate Cancer: The TARGET Clinical Trial Protocol.

Area of Science:

• Urology
• Radiology
• Oncology

Background:

• Multiparametric MRI (mpMRI) aids in detecting clinically significant prostate cancer (csPC), typically Gleason grade group (GG) ≥2.
• Current standard biopsy combines targeted and systematic sampling, increasing csPC detection but also overdiagnosing insignificant PC (GG 1).
• Perilesional sampling around MRI lesions is proposed to improve targeting accuracy and reduce GG 1 detection.

Purpose of the Study:

• To evaluate the diagnostic performance of a targeted + perilesional biopsy scheme for csPC detection.
• To compare this experimental scheme against the standard targeted + systematic biopsy approach.
• To assess differences in detecting insignificant (GG 1) and aggressive (GG ≥3) prostate cancer between the two schemes.

Main Methods:

• A prospective, multicentre, open-label, comparative clinical trial (TARGET).
• Each patient serves as their own control, undergoing targeted, perilesional, and systematic biopsies.
• Primary endpoint: sensitivity and specificity of targeted + perilesional vs. targeted + systematic schemes for csPC detection.

Main Results:

• The trial compares two prostate biopsy approaches: targeted + perilesional versus targeted + systematic.
• It aims to determine if sampling around MRI lesions maintains csPC detection rates.
• The study also investigates the reduction in detecting low-risk prostate cancer with the experimental approach.

Conclusions:

• The TARGET trial will provide crucial data on the efficacy of targeted + perilesional biopsy for prostate cancer diagnosis.
• Findings may lead to refined biopsy strategies, improving csPC detection and reducing overdiagnosis.
• This research has the potential to optimize prostate cancer management and patient outcomes.