Purpose
Most men with elevated serum prostate-specific antigen (PSA) levels and negative biopsies require repeat biopsy because of the lack of a sensitive and specific prostate cancer (CaP) detection test. This study evaluated the diagnostic potential of a duplex assay for CaP by quantifying transcript levels of α-methylacyl-CoA racemase (AMACR) and prostate-cancer antigen 3 (PCA3) in urine sediments following prostatic message.
Materials and Methods
Urine sediments from 92 patients, 43 with 49 without CaP were collected after digital rectal examination. Transcript levels of AMACR, PCA3, and PSA in total RNA isolated from these samples were determined by absolute qRT-PCR. AMACR and PCA3 scores were obtained by normalizing the transcript level to that of PSA for each sample and multiplying by 100.
Results
AMACR (p=0.006) and PCA3 (p=0.014) scores, but not serum PSA (p=0.306), discriminated specimens from patients with and without CaP, Receiver-operating-characteristic analysis established the diagnostic cutoff scores for the AMACR and PCA3 tests at 10.7 and 19.9, respectively. As determined from these cutoff scores, the AMACR test has 70% (95% CI, 56-83%) sensitivity and 71% (95% CI, 59-84%) specificity, whereas the PCA3 test has 72% (95% CI, 59-85%) sensitivity and 59% (95% CI, 45-73%) specificity for CaP detection. The combined use of AMACR and PCA3 scores in a dual-marker test increased sensitivity to 81% (95% CI, 70-93%) and specificity to 84% (95% CI, 73-94%).
Conclusions
Urinary AMACR and PCA3 tests were both superior to serum PSA test for detecting CaP. Their combined use in a dual-marker test further improved sensitivity and accuracy and could be used as a surveillance test after repeat negative prostate biopsies.