Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy
- 1 June 2020
- journal article
- research article
- Published by Future Medicine Ltd in Future Oncology
- Vol. 16 (16), 1083-1089
- https://doi.org/10.2217/fon-2020-0056
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.This publication has 17 references indexed in Scilit:
- Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trialThe Lancet Oncology, 2019
- Radiation with or without Antiandrogen Therapy in Recurrent Prostate CancerThe New England Journal of Medicine, 2017
- Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trialThe Lancet Oncology, 2016
- Impact of Age on Quality-of-life Outcomes After Treatment for Localized Prostate CancerEuropean Urology, 2015
- Synergistic action of image-guided radiotherapy and androgen deprivation therapyNature Reviews Urology, 2015
- Sexual Bother in Men with Advanced Prostate Cancer Undergoing Androgen Deprivation TherapyThe Journal of Sexual Medicine, 2014
- Adjuvant Radiotherapy Versus Wait-and-See After Radical Prostatectomy: 10-year Follow-up of the ARO 96–02/AUO AP 09/95 TrialEuropean Urology, 2014
- The Timing of Salvage Radiotherapy After Radical Prostatectomy: A Systematic ReviewInternational Journal of Radiation Oncology*Biology*Physics, 2012
- Adjuvant Radiotherapy for Pathological T3N0M0 Prostate Cancer Significantly Reduces Risk of Metastases and Improves Survival: Long-Term Followup of a Randomized Clinical TrialJournal of Urology, 2009
- Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911)The Lancet, 2005