Phase 2
Completed N=40
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT01393730 ↗Enrolled (actual)
40
Serious AEs
31.6%
Results posted
Jun 2017
Primary outcomePrimary: Number of Participants With Androgen Receptor (AR) Related Mutations — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Androgen Receptor (AR) Related Mutations |
1 | — |
| SECONDARY Change in Serum Levels of Testosterone |
0.25 | — |
| SECONDARY Prostate-Specific Antigen (PSA) Response |
34 | — |
| SECONDARY Time to PSA Progression |
5 | — |
| SECONDARY Best Overall Response |
6 | — |
| SECONDARY Time to Progression (TTP) |
11 | — |
| SECONDARY Presence of AR Amplification |
10 | — |
| SECONDARY Change in Serum Androgen Levels |
1.2 | — |
| SECONDARY Change in Circulating Tumor Cells (CTCs) Levels |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of adenocarcinoma of the prostate
- Castrate resistant disease
- Metastatic disease
- Normal organ and marrow function
- Subjects with partners of childbearing potential must be willing to use adequate methods of birth control
Exclusion Criteria
- Uncontrolled intercurrent illness
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- History of a different malignancy unless disease-free for at least 5 years
- Known brain metastasis
- History of gastrointestinal disorders
- Prior therapy with abiraterone acetate
- HIV-positive individuals on antiretroviral therapy
- Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
- Atrial fibrillation or other cardiac arrhythmia requiring therapy
- Thromboembolism in the last 6 months
Data sourced from ClinicalTrials.gov (NCT01393730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.