Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.