Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer. PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.
Timeline
- Start
- 2012-05
- Primary completion
- 2021-11-01
- Completion
- 2025-09-04
Outcome
Missed primary endpoint
registry analysis (superiority test); ADT + RT vs TAK-700 + ADT + RT; p = 0.55; Hazard Ratio (HR) 0.83 (95% CI 0.47 to 1.48) NCT01546987 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orteronel | Small molecule | 300 mg | Oral |
| Background | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Background | Flutamide | Small molecule | 250 mg | Oral |
| Background | Goserelin | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | — |
| Background | Triptorelin | Other / unclassified | — | — |
| Background | buserelin | Unknown | — | — |