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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 15, 2012
First Posted Date April 10, 2012
Last Update Posted Date October 16, 2014
Study Start Date January 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2012)
Treatment duration follow-up for each patient. [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 5, 2012)
  • Blood samples [ Time Frame: 1 year ]
    PSA and Testosterone measurement
  • Quality of Life measurements [ Time Frame: 1 year ]
    EORTC documents
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer
Official Title Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population • Male patients for whom hormone treatment for advanced prostate cancer is indicated
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Vantas
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2014)
142
Original Estimated Enrollment
 (submitted: April 5, 2012)
300
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility 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))

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574846
Other Study ID Numbers THE VANTAS STUDY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor Orion Corporation, Orion Pharma
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Björk, MD Urology Dep. Skane University Hospital, Malmoe, Sweden
PRS Account Orion Corporation, Orion Pharma
Verification Date October 2014