drugset / Trial / NCT03488810

Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer

NCT03488810 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-03-10
Primary completion
2026-06-15
Completion
2026-06-15

Outcome

Outcome not reported

Stopped: “Extended study timelines and additional budget could no longer be supported.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral
Comparator Bicalutamide Other / unclassified — Oral
Comparator Flutamide Small molecule — Oral

Indications