PCA3 as a second-line biomarker in a prospective controlled randomized opportunistic prostate cancer screening...

Area of Science:

• Urology
• Oncology
• Biomarker Research

Background:

• Prostate cancer (PCa) screening often involves prostate-specific antigen (PSA) and digital rectal examination (DRE).
• Second-line biomarkers are needed to improve diagnostic accuracy and reduce unnecessary biopsies in opportunistic screening settings.

Purpose of the Study:

• To compare the performance of the PCA3 biomarker as a second-line test against the European Randomised Study of Screening for Prostate Cancer risk calculator model 3 (ERSPC RC-3).
• To evaluate the impact of PCA3 on biopsy decisions and detection rates in men undergoing opportunistic prostate cancer screening.

Main Methods:

• A cohort of 5,199 men aged 40-75 years underwent PSA screening and DRE.
• Men with normal DRE and PSA ≥3ng/ml received a PCA3 test.
• Biopsies were performed for PCA3 ≥35, while PCA3 <35 patients were randomized to biopsy or observation, with comparisons to ERSPC RC-3 predictions.

Main Results:

• PCA3 testing was performed on 838 men (16.1%).
• PCa detection rates were 40.9% in PCA3(+) and 14.7% in PCA3(-) groups.
• Using PCA3 could have spared 64.1% of biopsies compared to ERSPC RC-3's 76.6%, while reducing false negatives for high-grade PCa by 37.1%.

Conclusions:

• PCA3-35 as a second-line biomarker can avoid 12.5% more biopsies than ERSPC RC-3 and reduces false negative cases by 36.2%.
• This approach may miss 9.1% of clinically significant PCa, necessitating strict follow-up with established PSA and DRE criteria for PCA3 <35 cases.