An investigator sponsored randomized, multicenter phase 2 study completed with generic oral itraconazole in men with metastatic castrate-resistant prostate cancer.
90% of men who achieved therapeutic levels of itraconazole had dramatic reductions in PSA which correlated significantly with Progression-Free Survival
It was concluded that high dose Itraconazole (600mg/day) may have modest antitumor activity in men with mCRPC that could potentially be associated with Hh pathway suppression, although an androgen-mediated effect cannot be excluded. Future studies will compare itraconazole with placebo in men with nonmetastatic CRPC, aiming to extend the metastasis-free survival duration in this population.
