Enzalutamide (Xtandi®) in patients with nonmetastatic, castration-resistant prostate cancer (CRPC)

Rothschedl E
Record ID 32018000333
English
Authors' objectives: Castration-resistant prostate cancer (CRPC) is a prostate cancer that keeps growing even when the testosterone level is reduced to very low levels. Enzalutamide (Xtandi®) is an orally bioavailable, organic, non-steroidal small-molecule androgen receptor (AR) signalling inhibitor. The US Food and Drug Administration (FDA) approved enzalutamide for nonmetastatic and metastatic CRPC in July 2018. To date, enzalutamide is not yet approved by the European Medicines Agency (EMA) for the assessed indication. The PROSPER trial assessed the efficacy and safety of enzalutamide versus placebo in patients with nonmetastatic CRPC and a rapidly rising prostate-specific antigen (PSA) level.
Authors' results and conclusions: The administration of enzalutamide in patients with nonmetastatic CRPC and a rapidly rising PSA prolonged MFS and delayed PSA progression and the use of subsequent antineoplastic therapy. However, the clinical benefit of enzalutamide reflected in OS prolongation and an improvement of the patients’ quality of life (QoL) has not been established yet. Final analyses of the PROSPER trial and further ongoing studies may provide information about whether prolonged MFS also implies prolongation of overall survival (OS). At any rate, the benefits of enzalutamide treatment need to be weighed against the risks, always considering the patients’ QoL. Additionally, a direct comparison of enzalutamide and apalutamide is needed to verify the optimal treatment for this patient population.
Details
Project Status: Completed
URL for project: https://aihta.at/page/horizon-scanning-in-der-onkologie/en
Year Published: 2018
URL for published report: http://eprints.aihta.at/1184/1/DSD_HSO_Nr.84.pdf
URL for additional information: http://eprints.aihta.at/1184/
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Prostatic Neoplasms, Castration-Resistant
  • Male
  • Androgen Receptor Antagonists
Keywords
  • Enzalutamide
  • Xtandi®
  • prostate cancer
  • castration-resistant
  • nonmetastatic
Contact
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
Contact Name: tarquin.mittermayr@aihta.at
Contact Email: office@aihta.at
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.