CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 190 enrolled
Drug / intervention
Abiraterone Acetate +3 moredrug
Likely dose
Abiraterone Acetate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01254864
NCT01254864Phase 2Completed

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

M.D. Anderson Cancer Center·interventional·Posted Dec 7, 2010·Updated Jan 27, 2025

In Brief

A Phase 2 clinical trial evaluating Abiraterone Acetate, Prednisone, and 2 other interventions for Prostate Cancer. Completed, enrolled 190 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 7, 2010
Enrollment StartMar 16, 2011
Primary CompletionDec 7, 2023
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 15.6 years ago

Interventions

Abiraterone Acetatedrug

1000 mg by mouth each day of a 28 day cycle.

Prednisonedrug

5 mg by mouth twice daily of a 28 day cycle.

Sunitinibdrug

37.5 mg by mouth daily for two weeks followed by a week of rest in a 28 day cycle.

Dasatinibdrug

100 mg by mouth each day of a 28 day cycle.