drugset / Trial / NCT00003645
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
Phase 3
Terminated
64 enrolled
M.D. Anderson Cancer Center
AstraZeneca · collabEastern Cooperative Oncology Group · collabNational Cancer Institute (NCI) · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
Timeline
- Start
- 1999-06-14
- Primary completion
- 2017-03-20
- Completion
- 2017-03-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 50 mg | Oral |
| Subject | flutamide | Small molecule | 10.8 mg | Intramuscular |