Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy
Year: 2025
Type: article
Abstract: 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.
Source: Figshare
Authors: Piet Dirix (3095901), Michiel Strijbos (5997548), Tom Van den Mooter (20839379), Nick Liefhooghe (15189265), Siska Van Bruwaene (8111972), Pieter Uvin (439163), Christophe Ghysel (5997527), Dieter Ost (20839382), Peter Schatteman (20839385), Samuel Bral (20839388), Benedikt Engels (3469514), Robbe Van den Begin (3542366), François-Xavier Otte (20839391), Thierry Roumeguere (20839394), Samuel Palumbo (20839397), Yannick Neybuch (20839400), Valérie Fonteyne (837666), Piet Ost (837668), Luc Dirix (61984)
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6902248171
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