Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

Condition(s) studied

Investigational drug(s) / intervention(s)

iMAB: no treatment until significant PSA increase as per treating physician at which point patient restarts ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide). Once PSA \< 0.2 ng/mL, treatment stops again.

cMAB: LHRH agonist or antagonist + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)

Study summary

This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization.

The primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.

Eligibility

Primary outcome measure(s)

• overall survival — 10 years from randomisation
  the overall survival (OS) using an iMAB regimen is non-inferior to continuous treatment.
• proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy (given as part of the induction phase) — 1 year from stopping the MAB therapy
  proportion of patients who do not restart within 1 year of interrupting their MAB therapy (given as part of the induction phase) is not less than 70%

Trial sites (9)

More European Organisation for Research and Treatment of Cancer - EORTC trials in Spain

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