drugset / Trial / NCT03488810
Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Comparator | Bicalutamide | Other / unclassified | — | Oral |
| Comparator | flutamide | Small molecule | — | Oral |