To this end, two pharmacodynamic trials (one in the neoadjuvant setting prior to radical prostatectomy (NCT02111187), and one in men with metastatic CRPC (NCT02115828)) are currently accruing patients to determine the effect of potent small-molecule SMO inhibitors (sonidegib and vismodegib, respectively) on Hh pathway activity in the tumor and microenvironment directly, rather than using the skin as a surrogate tissue. The gene discussed is SMO; the disease is neoplasm.