drugset / Trial / NCT01368588
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Phase 3
Active not recruiting
2590 enrolled
Radiation Therapy Oncology Group
NRG Oncology · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
Timeline
- Start
- 2011-07
- Primary completion
- 2025-04-17
- Completion
- 2031-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) vs Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2); p = 0.55 NCT01368588 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bicalutamide | Other / unclassified | — | Oral |
| Subject | Degarelix | Other / unclassified | — | Subcutaneous |
| Subject | Flutamide | Small molecule | — | Oral |
| Subject | Goserelin | Other / unclassified | — | Subcutaneous |
| Subject | Leuprolide | Other / unclassified | — | Subcutaneous |
| Subject | Triptorelin | Other / unclassified | — | Subcutaneous |
| Subject | buserelin | Unknown | — | Subcutaneous |