Publication
Vlaeminck-Guillem V, Ruffion A, André J, Devonec M, Paparel P. Urology 2010;75:447-53
- This review paper discusses the development of the Prostate CAncer gene 3 (PCA3) Assay and the scientific evidence regarding its ability to predict biopsy outcome and prostate cancer (PCa) prognosis
- Low specificity of serum prostate specific antigen (PSA) for detection of PCa has led to many unnecessary prostate biopsies and overdiagnosis/overtreatment of non-progressing, indolent cancers. It therefore seems necessary to supplement PSA with high performance biomarkers that can distinguish with greater specificity cancer from non-cancer patients and at the same time identify patients with aggressive cancer
- PCA3 is highly PCa-specific; it has a 66-100 times higher expression in PCa tissue than in normal prostate tissue
- The PROGENSA™ PCA3 Assay measures PCA3 in urine samples collected after an attentive, 3-stroke digital rectal examination (DRE). The informative rate of samples collected according to this procedure is high, approaching 100%
- The review discusses 11 clinical studies evaluating the clinical utility of PCA3 in PCa detection, of which 7 used the PROGENSA™ PCA3 Assay
- Receiver Operating Curve (ROC) analyses showed an Area Under the Curve (AUC) for PCA3 of approximately 0.7. The AUC ROC for PCA3 was consistently higher than that for serum total PSA or % free PSA. The sensitivity of the PCA3 Assay was less than that of serum total PSA but the specificity, negative predictive value (NPV) and positive predictive value (PPV) were higher, in particular in men with a previous negative biopsy. PCA3 is, in contrast to PSA, not correlated with prostate volume. PCA3 Scores were similar regardless of serum PSA level, including a PSA level of 4-10 ng/mL, where the performance of PSA for PCa detection is insufficient
- Patients with atypical small acinar proliferation (ASAP) or high-grade prostatic intraepithelial neoplasia (HGPIN) had a significantly higher mean PCA3 Score than men with a non-cancerous biopsy. However, it remains to be determined whether an elevated PCA3 Score that is associated with HGPIN represents a greater risk of developing PCa and requires specific patient management
- Recent studies suggest a correlation between the PCA3 Score and tumour volume, pT stage and Gleason score and that the PCA3 Score can help to discriminate between indolent and significant cancer
- It was concluded that the PCA3 Assay constitutes an invaluable aid in deciding whether new biopsies should be carried out on patients who had at least one previous negative biopsy. The PCA3 Assay fulfils many of the requirements for a marker to be successful in clinical practice:
- An easily accessible biological sample (urine sample after DRE)
- A reproducible technique across testing laboratories
- Good statistical accuracy
- The PCA3 Assay brings specificity to PSA and could be a useful complement. In addition, the PCA3 Score can be combined with other clinical variables and biomarkers into nomograms
More information: Article at PubMed