Objective To determine the value of the ratio of free prostate-specifi
c antigen (fPSA) to total PSA (tPSA) in the diagnosis of benign prosta
tic hyperplasia (BPH) and prostate cancer in a cohort of patients unde
rgoing prostatic transrectal ultrasonography (TRUS), Patients and meth
ods The study comprised 153 patients (99 with BPH and 54 with prostate
cancer) undergoing diagnostic TRUS of the prostate. Patients with a t
PSA of >30 ng/mL were excluded from analysis. Free PSA was assayed usi
ng an immunoassay specific for unbound PSA (CanAg Diagnostics, Sweden)
. Total PSA was measured using the HybriTech Tandem-R PSA immunoradiom
etric assay in routine clinical use and this estimate was validated us
ing the CanAg tPSA assay. Results The measurements of tPSA from both a
ssay systems correlated closely. The f/tPSA ratios in patients with pr
ostate cancer were significantly lower than in those with BPH (median
values 0.152 and 0.2, respectively, P<0.01). In patients with prostate
cancer, the median f/t PSA levels apparently declined with increasing
tPSA levels but in those with BPH, the levels of tPSA were not signif
icantly associated with the f/tPSA ratio; the ratios did not vary sign
ificantly with age in either group, A f/tPSA ratio at a threshold of 0
.16 had positive and negative predictive values of 44% and 74%, respec
tively; the corresponding values for a tPSA of >4 ng/ml, were 30% and
52%. Conclusion The f/tPSA ratio differs significantly between patient
s with BPH and cancer but because there is a considerable overlap of f
/tPSA ratios between the groups, f/tPSA values alone were not sufficie
ntly specific to be used as a single diagnostic test.