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

Prostate Cancer Clinical Trial

— Vantas  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574846
• Other study ID #: THE VANTAS STUDY
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: October 15, 2014
• Start date: January 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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))

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Sweden	Urology Dep. Skane Univeristy Hospital	Malmoe

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment duration follow-up for each patient.		1 year	No
Secondary	Blood samples	PSA and Testosterone measurement	1 year	No
Secondary	Quality of Life measurements	EORTC documents	1 year	No