Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT01574846
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas® for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 142
- Male patients for whom hormone treatment for advanced prostate cancer is indicated
- Age > 18 years.
- Documented elevated PSA levels.
Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment duration follow-up for each patient. 1 year
- Secondary Outcome Measures
Name Time Method Quality of Life measurements 1 year EORTC documents
Blood samples 1 year PSA and Testosterone measurement
Trial Locations
- Locations (1)
Urology Dep. Skane Univeristy Hospital
🇸🇪Malmoe, Sweden