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ORIGINAL PAPERPCA3: A new tool to diagnose prostate cancer (PCa)and a guidance in biopsy decisions.Preliminary report of the UrOP study.Fabio Galasso 1 , Renato Giannella 1 , Paola Bruni 3 , Rosaria Giulivo 3 ,Vittorino Ricci Barbini 4 , Vincenzo Disanto 5 , Rosario Leonardi 6 ,Vito Pansadoro 2 , Giuseppe Sepe 11Casa di Cura Malzoni “Villa Platani”, Avellino, Italy;2Casa di Cura Pio XI, Roma, Italy;3Laboratorio di Biodiagnostica Montevergine, Malzoni, Avellino, Italy;4Ospedale di Poggibonsi (Siena), Italy;5Casa di Cura S. Rita, Bari, Italy;6Clinica Basile, Catania, ItalySummaryObjectives: PCA3 is a prostate specific non-coding mRNA that is significantly overexpressedin prostate cancer tissue. Urinary PCA3 levels have been associated withprostate cancer grade suggesting a significant role in the diagnosis of prostate cancer.We measured urinary PCA3 score in 925 subjects from several areas of Italy assessingin 114 the association of urinary PCA3 score with the results of prostate biopsy.Material and Methods: First-catch urine samples were collected after digital rectal examination(DRE). PCA3 and PSA mRNA levels were measured using Trascription-mediated PCR amplification.The PCA3 score was calculated as the ratio of PCA3 and PSA mRNA (PCA3 mRNA/PSAmRNA x 1000) and the cut off was set at 35.Results: A total of 925 PCA3 tests were performed from December 2008 to January 2010. Therate of informative PCA3 test was 99%, with 915 subjects showing a valid PCA3 score value: 443patients (48.42%) presented a PCA3 score > = 35 (cut-off) whereas the remaining 472 patients(51.58%) presented a PCA3 score lower the cut-off limit (< 35). Of the 443 patients with PCA3score > = 35, 105 (23.70%) underwent biopsy or rebiopsy. We found that 27 patients (25.71%) hadno tumour at biopsy, 37 (35.24%) had HGPIN or ASAP and 41 (39.05%) had a cancer. Moreover,including the additonal 9 patients with PCA3 < 35, who underwent biopsy post PCA3 results, ourdata indicate that patients with negative biopsy (n = 31) show lower PCA3 score (mean = 54.9)compared with patients with positive biopsy (n = 45) (mean = 141.6) (p = 0.000183; two-tailed t-student test). The mean PCA3 score (79.6) for the patients diagnosed with HGPIN/ASAP at biopsy(n = 38) was intermediate between patients with negative and positive biopsy.Conclusions: Our results indicate that the PCA3 score is a valid tool for prostate cancer detectionand its role in making better biopsy decisions. This marker consents to discriminatepatients who have to undergo biopsy from patients who only need be actively surveilled:Quantitative PCA3 score is correlated with the probability of a positive result at biopsy.KEY WORDS: Prostate Cancer Gene 3 (PCA3); Prostate Specific Antigen (PSA); prostate cancer (PCa),biopsy; Digital Rectal examination (DRE); Benign Prostatic Hyperplasia (BPH).Submitted 15 February 2010; Accepted 10 March 2010INTRODUCTIONPrior to the 1990s, digital rectal examination (DRE) ofprostate and measurements of serum prostatic acidphophatase (PAP) were utilised to screen patients at riskfor prostate cancer (PCa). Subsequently, Prostate SpecificAntigen (PSA) has been used worldwide for the earlydetection of prostate cancer (1). However, PSA-basedscreening has led to an increase in the diagnosis of lowvolume/low grade cancer that in some cases will notprogress clinically during lifetime (2, 3).Risk characterization based exclusively on serum totalPSA (tPSA) values presents several inherent difficulties.PSA is apparently specific for prostate tissue but not forprostate cancer. Elevated values of serum tPSA are foundin many benign conditions involving enlargement of theArchivio Italiano di Urologia e Andrologia 2010; 82, 15