NCT03488810

Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer

Radiotherapy and 6-month Androgen Deprivation Therapy With or Without Apalutamide in Intermediate and Limited High Risk Localized Prostate Cancer: a Phase III Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial to determine if the combination of apalutamide with 6 months of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an improvement of disease-free survival (DFS) evaluated by the treating physician, in comparison to the combination of radiation and androgen deprivation therapy without the addition of apalutamide.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Radiation Therapy	Dose escalated Intensity-Modulated Radiation therapy (IMRT) with conventional fractionation, hypofractionation and prostate brachytherapy are allowed.
DRUG	Apalutamide	240 mg PO daily, started the same day as the first LHRHa injection, for 6 months
DRUG	Luteinising Hormone Releasing Hormone analog agonist (LHRHa)	2 injections of a three-monthly LHRH agonist depot
DRUG	Non-steroidal anti-androgen	Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection

Timeline

• Start date: 2020-03-10
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2018-04-05
• Last updated: 2020-08-17