Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy.

Apalutamide, a competent inhibitor of the androgen receptor, has shown promising clinical efficacy results for patients with advanced prostate cancer. Here, we describe the rationale and design for the SAVE trial, a multi-center, Phase II study, wherein 202 men with biochemical progression after radical prostatectomy are randomly assigned 1:1 to apalutamide plus salvage radiotherapy (SRT) or androgen-deprivation therapy with an luteinizing hormone-releasing hormone agonist or antagonist plus SRT. The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment. The key secondary objectives are to assess quality of life, to evaluate the safety profile and the short-term efficacy of apalutamide in combination with SRT. ClinicalTrials.gov identifier: NCT03899077.

Future oncology (London, England). 2020 May 01 [Epub ahead of print]

Piet Dirix, Michiel Strijbos, Tom Van den Mooter, Nick Liefhooghe, Siska Van Bruwaene, Pieter Uvin, Christophe Ghysel, Dieter Ost, Peter Schatteman, Samuel Bral, Benedikt Engels, Robbe Van den Begin, François-Xavier Otte, Thierry Roumeguere, Samuel Palumbo, Yannick Neybuch, Valérie Fonteyne, Piet Ost, Luc Dirix

Department of Radiation Oncology, Iridium Kankernetwerk, Antwerp, Belgium., Department of Medical Oncology, GZA Sint-Augustinus Hospital, Antwerp, Belgium., Department of Radiation Oncology, AZ Groeninge, Kortrijk, Belgium., Department of Urology, AZ Groeninge, Kortrijk, Belgium., Department of Urology, AZ Sint-Jan, Bruges, Belgium., Department of Urology, AZ Sint-Blasius, Dendermonde, Belgium., Department of Urology, OLV, Aalst, Belgium., Department of Radiation Oncology, OLV, Aalst, Belgium., Department of Radiation Oncology, UZ Brussel, Brussels, Belgium., Department of Radiation Oncology, Institut Jules Bordet, Brussels, Belgium., Department of Urology, Hôpital Erasme, Brussels, Belgium., Department of Radiation Oncology, Hôpital Sainte Elisabeth, Namur, Belgium., Department of Radiation Oncology, Hôpital Jolimont, La Louvière, Belgium., Department of Radiation Oncology, UZ Gent, Ghent, Belgium.