PCA3 Materials & News

Tombal B, Ameye  F, de la Taille A, de Reijke T, Gontero P, Haese A, Kil P, Perrin P, Remzi M, Schröder J, Speakman M, Volpe A, Meesen B, Stoevelaar H. World J Urol 2011 DOI 10.1007/s00345-011-0721-0

• In this study, a panel of 12 European urologists with expertise in prostate cancer (PCa) established criteria for the appropriateness of PCA3 testing, prostate biopsy and active surveillance using the RAND/UCLA Appropriateness Method for a set of theoretical clinical profiles systematically constructed by combining clinical variables. The outcome suggests that the experts believe that PCA3 can have an added value in clinical practice for taking biopsy and treatment decisions, depending on the clinical profile
• A total of 108 clinical profiles were constructed for assessing the appropriateness of the PCA3 Assay. These profiles were unique combinations of clinical variables predicting PCa risk (i.e. life expectancy, digital rectal exam [DRE], prostate specific antigen [PSA], prostate volume, initial or repeat biopsy, etc.).
• The appropriateness of a prostate biopsy for each of these profiles was assessed for five different scenarios, (no PCA3 Score [PCA3 not performed] and PCA3 Scores < 20, 20-35, 35-50 and > 50) yielding 540 different theoretical clinical cases.
• The appropriateness of active surveillance was rated for 64 hypothetical profiles at low risk of significant PCa (T1c or T2a, PSA < 10 ng/mL and Gleason sum < 7) constructed using clinical variables relevant in active surveillance decisions, i.e. life expectancy, clinical stage, % of positive cores, PSA and PCA3 Score (no PCA3 Score [PCA3 not performed], < 20, 20-50, and > 50).
• The expert panel judged that PCA3 testing was appropriate for 40% of the 108 patient profiles, mainly for men with ≥ 1 negative biopsy, a PSA ≥ 3 ng/mL and a life expectancy of ≥ 10 years (Figure 1).
• Prostate biopsy was considered appropriate in 42% of cases. Whereas a life expectancy of < 10 years, ≥ 2 negative biopsies and a PCA3 Score < 20 decreased the appropriateness of biopsy, it was increased with a PSA ≥ 3 ng/mL and a PCA3 Score > 50.
• Active surveillance was judged appropriate for 22% of the 64 theoretical cases of men at low risk of significant PCa, particularly for men with a life expectancy < 10 years, stage T1c PCa, ≤ 20% of positive cores and a PSA < 3 ng/mL. PCA3 Scores < 20 supported the decision for active surveillance in certain cases, depending on life expectancy, stage, and % of positive cores, whereas scores > 20, and in particular > 50, discouraged active surveillance (Figure 2).
• It needs to be considered that some hypothetical profiles used in this study may not exist in clinical practice, whereas others may be very common. Therefore, the prevalence of the different hypothetical profiles in real life clinical practice needs to be investigated in future studies.
• The outcome of this study suggests that experts believe that PCA3 testing can often be valuable for supporting biopsy decisions in men suspicious of having PCa, particularly for those with ≥ 1 negative biopsy, PSA ≥ 3 ng/mL and a life expectancy ≥ 10 years. In men with low-risk PCa, the PCA3 Assay can provide reassurance for the physician and patient in their decision for active surveillance.

Figure 1. PCA3 testing is particularly appropriate for men with a life expectancy of ≥ 10 years, ≥1 negative biopsy, and a PSA ≥ 3 ng/mL

Figure 2. PCA3 Scores < 20 reassure a decision for active surveillance whereas scores > 20, and in particular > 50, discourage active surveillance

More information: Abstract/Article at PubMed