Metastatic Hormone Refractory Prostate Cancer
Conditions
Keywords
Prostate Cancer, Hormone Refractory, patupilone, docetaxel
Brief summary
The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be ≥ 18 years of age * Confirmed and documented diagnosis of prostate cancer * Confirmed and documented evidence of progression of disease (hormone refractory) * Low testosterone levels * Chemotherapy-naïve
Exclusion criteria
* Recent radiation therapy (within 4 weeks) * Known brain metastasis * Peripheral neuropathy * Active diarrhea * Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections * Allergic reactions to patupilone or docetaxel or prednisone or similar compounds Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor response based on PSA decrease | Every 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measurable soft tissue response for both regimens | Every 6 weeks or every 12 weeks if patient has bone disease for bone scan |
Countries
Australia, Belgium, France, Germany, Italy, Singapore, Spain, United States
Outcome results
None listed