drugset / Trial / NCT03809000
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
Phase 2
Active not recruiting
188 enrolled
RTOG Foundation, Inc.
Astellas Pharma Inc · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.
Timeline
- Start
- 2019-04-15
- Primary completion
- 2023-04-07
- Completion
- 2029-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | 160 mg | — |
| Comparator | Bicalutamide | Other / unclassified | 50 mg | — |
| Background | Decapeptyl | Unknown | — | Other |
| Background | Goserelin | Other / unclassified | — | Other |
| Background | Leuprolide | Other / unclassified | — | Other |