Objectives: Two different studies were performed. The aim of the first study was to define whether the measurement of the ratio between free and total prostate-specific antigen (f/t PSA) in serum may enhance the ability of PSA-based screening for early detection of prostate cancer in men with elevated serum PSA levels. A second study was undertaken to investigate the value of f/t PSA ratio in serum to improve the specificity of prostate cancer screening in men with serum PSA levels between 2.5 and 10.0 ng/mL.
Methods: In a retrospective study of 266 men with elevated PSA levels and proven biopsy results, f/t PSA levels were measured using deep frozen serum samples. In a second study we enrolled 158 men with elevated PSA levels according to age reference ranges apparent from our current PSA screening study with additional measurement of the f/t PSA ratio. All study volunteers with a free f/t PSA ratio cutoff point of < or = 22% underwent digital rectal examination, transrectal ultrasonography, and biopsy of the prostate. Free and total PSA levels were measured with the Delfia PSA dual label f/t PSA kit (Wallac Oy Turku, Finland).
Results: 106 of 158 men with elevated total PSA values between 2.5 and 10.0 ng/mL (group 1) have been further evaluated and 37 prostate cancers were detected. Mean percentage of free PSA was 10% in men with cancer and 22% in men with benign prostatic hyperplasia. Using a f/t PSA ratio of < or = 22% as a biopsy criterion 30% of the negative biopsies could be eliminated while still detecting 98% carcinomas.
Conclusions: Measurement of f/t PSA reduces the number of unnecessary biopsies in PSA screening without missing many cancers.