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

NCT01254864 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-01-27

Study results available
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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.

Conditions

Interventions

DRUG

Abiraterone Acetate

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

DRUG

Prednisone

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

DRUG

Sunitinib

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

DRUG

Dasatinib

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

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Paul Corn, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-16
Primary Completion
2023-12-07
Completion
2023-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254864 on ClinicalTrials.gov