Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Treatment duration follow-up for each patient.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients for whom hormone treatment for advanced prostate cancer is indicated
- •Age > 18 years.
- •Documented elevated PSA levels.
Exclusion Criteria
- •Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))
Outcomes
Primary Outcomes
Treatment duration follow-up for each patient.
Time Frame: 1 year
Secondary Outcomes
- Quality of Life measurements(1 year)
- Blood samples(1 year)