NCT01574846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

February 15, 2012

Last Update Submit

October 15, 2014

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment duration follow-up for each patient.

    1 year

Secondary Outcomes (2)

  • Blood samples

    1 year

  • Quality of Life measurements

    1 year

Study Arms (1)

Vantas

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Male patients for whom hormone treatment for advanced prostate cancer is indicated
  • Age \> 18 years.
  • Documented elevated PSA levels.

You may not qualify if:

  • Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Dep. Skane Univeristy Hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Thomas Björk, MD

    Urology Dep. Skane University Hospital, Malmoe, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

April 10, 2012

Study Start

January 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

SE(1)