drugset / Trial / NCT01254864

Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies

NCT01254864 ↗

RandomizedCrossoverOpen-labelTreatment

Summary

You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body. This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain types of leukemia. The use of these drugs in prostate cancer and in combination with abiraterone acetate and prednisone is investigational. Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Timeline

Start
2011-03-16
Primary completion
2023-12-07
Completion
2023-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Subject Sunitinib Small molecule 37.5 mg Oral
Subject dasatinib anhydrous Small molecule 100 mg Oral
Background Prednisone Other / unclassified 5 mg Oral

Indications