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

• ClinicalTrials.gov Identifier: NCT01574846
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: October 16, 2014
• Sponsor: Orion Corporation, Orion Pharma
• 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

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

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

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