NCT01393730

Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mary-Ellen Taplin, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.

Detailed description

Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2 cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood tests. Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other specialized blood test.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone acetate
DRUG	Dutasteride
DRUG	Prednisone

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-01-01
• Completion: 2017-03-15
• First posted: 2011-07-13
• Last updated: 2018-03-15
• Results posted: 2017-06-14

Locations

4 sites across 1 country: United States