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OpenTrials
Completed

NCT Number: NCT01574846

Prospective Multicentre Non-interventional 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Urology Dep. Skane Univeristy Hospital

Malmö, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Primary outcomes

  1. Treatment duration follow-up for each patient.

    Time frame: 1 year

Secondary outcomes

  1. Blood samples

    Time frame: 1 year

    PSA and Testosterone measurement

  2. Quality of Life measurements

    Time frame: 1 year

    EORTC documents

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Acronym: Vantas

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2012
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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