Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP

Summary

This is a phase II randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist (arm A) versus anti-androgen therapy (AAT) with apalutamide 240mg daily (arm B) in hormone-naïve patients with biochemical progression after radical prostatectomy. All subjects will receive salvage radiotherapy as standard of care and will be randomly assigned in a 1:1 ratio to receive either 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist through 6 monthly, two 3-monthly or one 6-monthly injections (control arm) or 6 28-day cycles of apalutamide 240mg daily (interventional arm). The study will include a screening phase, treatment phase, and a post-treatment phase. The primary objective of the trial is to compare sexual function between the 2 groups based on the Expanded Prostate cancer Index Composite (EPIC)-26 sexual domain scores at 9 months after start of hormonal treatment.

Timeline

Start

2019-04-05

Primary completion

2025-08

Completion

2025-12

Publications

• Dirix P, Strijbos M, den Mooter TV, Liefhooghe N, Bruwaene SV, Uvin P, Ghysel C, Ost D, Schatteman P, Bral S, Engels B, den Begin RV, Otte FX, Roumeguere T, Palumbo S, Neybuch Y, Fonteyne V, Ost P, Dirix L. Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy. Future Oncol. 2020 Jun;16(16):1083-1189. doi: 10.2217/fon-2020-0056. Epub 2020 May 1.

Drugs

Indications