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

October 15, 2014 updated by: Orion Corporation, Orion Pharma

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmoe, Sweden
        • Urology Dep. Skane Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

• Male patients for whom hormone treatment for advanced prostate cancer is indicated

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Vantas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment duration follow-up for each patient.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood samples
Time Frame: 1 year
PSA and Testosterone measurement
1 year
Quality of Life measurements
Time Frame: 1 year
EORTC documents
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Thomas Björk, MD, Urology Dep. Skane University Hospital, Malmoe, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THE VANTAS STUDY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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