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

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ClinicalTrials.gov Identifier: NCT01574846
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Study Description
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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.

Condition or disease
Prostate Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.
Study Start Date : January 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Vantas


Outcome Measures
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Primary Outcome Measures :
  1. Treatment duration follow-up for each patient. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Blood samples [ Time Frame: 1 year ]
    PSA and Testosterone measurement

  2. Quality of Life measurements [ Time Frame: 1 year ]
    EORTC documents


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
• Male patients for whom hormone treatment for advanced prostate cancer is indicated
Criteria

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))

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574846


Locations
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Sweden
Urology Dep. Skane Univeristy Hospital
Malmoe, Sweden
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Thomas Björk, MD Urology Dep. Skane University Hospital, Malmoe, Sweden
More Information
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01574846    
Other Study ID Numbers: THE VANTAS STUDY
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases