Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer (Vantas)

Orion Pharma

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01574846

THE VANTAS STUDY

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

142 participants in 1 patient group

Vantas