Ketoconazole for the Treatment of Docetaxel-Naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC): A Systematic Review

Document Type : Systematic Review and Meta-analysis


Department of Urology, Hasan Sadikin Academic Medical Center, Universitas Padjajaran Bandung, Indonesia.


Objective: This systematic review aimed to determine the efficacy of ketoconazole in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Materials and Methods: A literature search was performed on four databases of PubMed, Google Scholar, Cochrane Database of Systematic Reviews, and Directory of Open Access Journals (DOAJ). The initial search resulted in 602 articles, which were progressively eliminated based on duplication, irrelevancy, and unsuitable methodology. A total of seventeen articles were included in the final analysis, including four randomized controlled trials, nine retrospective cohorts, and four prospective cohorts, with a total population of 1,095 patients. A 200-400 mg, tid dose of ketoconazole was used in these studies along with corticoid replacement therapy with hydrocortisone, 20-30 mg in the morning and 10-20 mg in the evening, or prednisone, 5 mg, bid. Results: Based on our findings, 8 out of 17 studies reported PSA decrease of >50% in approximately half of the population, with a more significant PSA response at 400 mg ketoconazole dosage, and the average progression-free survival (PFS) of 2.6-14.5 months, or time to progression of 3.2-6.7 months. Conclusion: Ketoconazole with corticosteroid could be an effective alternative for the treatment of mCRPC with a satisfactory PSA response and disease progression.


Main Subjects

Volume 22, Issue 10
October 2021
Pages 3101-3107
  • Receive Date: 24 March 2021
  • Revise Date: 09 May 2021
  • Accept Date: 04 October 2021
  • First Publish Date: 04 October 2021