PCA3 score and prostate cancer diagnosis at repeated saturation biopsy. Which cut-off: 20 or 35?

Abstract

ARTIcLE INFO _________________________________________________________ ___________________Purpose: To compare PCA3 score cut-off of 35 vs 20 in PCa diagnosis in patients undergoing repeated saturation prostate biopsy (SPBx). Material and Methods: From January 2010 to May 2011, 118 patients (median 62.5 years) with primary negative extended biopsy underwent a transperineal SPBx (median 30 cores) for persistent suspicion of PCa. The indications for repeated biopsy were: persistently high or increasing PSA values; PSA > 10 ng/mL, PSA values between 4.1-10 or 2.6-4 ng/mL with free/total PSA ≤ 25% and ≤ 20%, respectively; moreover, before performing SPBx urinary PCA3 score was evaluated. Results: All patients had negative DRE and median PSA was 8.5 ng/mL (range: 3.7-24 ng/mL). A T1c PCa was found in 32 patients (27.1%): PCA3 score was 59 (median; range: 7-201) in the presence of PCa and 35 (median; in the absence of cancer (p < 0.05). In the presence of ASAP and HGPIN median PCA3 score was 109 (range: 42-253) and 40 (range: 30-140), respectively. Diagnostic accuracy, sensitivity, specificity, PPV and NPV of PCA3 score cut-off of 20 vs 35 in PCa diagnosis were 44.9 vs 50%, 90.6 vs 71.9%, 27.9 vs 41.8%, 31.9 vs 31.5% and 88.9 vs 80%, respectively. ROC analysis demonstrated an AUC for PCA3 ≥ 20 vs ≥ 35 of 0.678 and 0.634, respectively. Conclusions: Our data suggest that PCA3 is more useful as an exclusion tool; moreover, setting a PCA3 cut-off at 20 vs 35, would have avoided 22.9 vs 38.1% of biopsies while missing 9.4% and 28% diagnosis of PCa.

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation

“…A total of 21 papers 45,46,85,86,[88][89][90][91][92][94][95][96][97][98][99][101][102][103][104][105][106] were identified which reported within-study comparisons between clinical assessment + PCA3 and/or clinical assessment + phi versus a comparator.…”

“…The PCA3 score report is a ratio of the PCA3 mRNA copies/ml to PSA mRNA copies/ml multiplied by 1000. The score can be used as a continuous measure but studies [45][46][47][48] have used threshold scores of 20, 25 or 35 to identify men who are at higher risk of an underlying cancer. The manufacturers of the PCA3 assay have recommended a threshold score of 25, with values 25 and higher suggesting the presence of cancer and values under 25 suggesting the absence of cancer.…”

Scrutiny of Prostate Cancer Antigen 3 Effectiveness as an Assist of Prostatic Specific Antigen in Screening and Early Diagnosis of Prostate Cancer: A Review

“…PCA3 reduces the number of unnecessary biopsies and post-biopsy infections (27). PCA3 score can remarkably prevent the number of unnecessary biopsies (32.4% of the cases referred to Urology Unit, Cannizzaro hospital, Catania, Italy) (28).…”

Diagnosis of prostate cancer via nanotechnological approach

“…Currently available clinical diagnostic methods for prostate cancer include biochemical assay, [12][13][14][15][16][17][18][19][20] biopsy, [21][22][23][24][25][26][27] digital rectal examination (DRE), [28][29][30][31][32] and transrectal ultrasonography [33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49] as described in Figure 2. Among these methods, the biochemical assay is used for initial screening.…”

“…The biochemical assay measures serum -a term meaning the processed medium from whole blood -prostate-specific antigen (PSA) level where a concentration 4 ng/mL is considered to indicate a risk of prostate cancer. [12][13][14][15][16][17][18][19][20] Since approval by the US Food and Drug Administration (FDA) 25 years ago, it has been used as the gold standard for the initial screening of the disease.…”