Biopsy and treatment decisions in the initial management of prostate cancer and the role of PCA3: a systematic analysis of expert opinion

Purpose: The Prostate CAncer gene 3 (PCA3) assay may guide prostate biopsy decisions and predict prostate cancer (PCa) aggressiveness. This study explored the appropriateness of (1) PCA3 testing; (2) biopsy; (3) active surveillance (AS) and the value of the PCA3 Score for biopsy and AS decisions. Methods: Using the RAND/UCLA appropriateness method, 12 urologists assessed the appropriateness of PCA3, biopsy and AS for theoretical patient profiles, constructed by combining clinical variables. They individually scored the appropriateness for all profiles using a 9-point scale. Based on the median score and extent of agreement, the appropriateness for each profile was calculated. Results: The PCA3 Assay was mainly considered appropriate in men with ≥1 negative biopsy, PSA ≥ 3 ng/mL and life expectancy (LE) ≥10 years. A LE < 10 years, ≥2 negative biopsies and PCA3 Score <20 decreased biopsy appropriateness, while PSA ≥ 3 ng/mL and PCA3 Score >50 increased it. In men without a prior biopsy, LE ≥ 10 years and a suspicious DRE, PCA3 did not affect biopsy appropriateness. In other men, a PCA3 Score <20 discouraged biopsy, while a value ≥35 supported biopsy. AS was mainly considered appropriate if LE < 10 years, T1c PCa, ≤20% positive cores and PSA < 3 ng/mL. A PCA3 Score <20 pleads for and higher scores (particularly >50) against AS. Conclusions: These findings illustrate in which men PCA3 can be of additional value when taking biopsy and treatment decisions in clinical practice.