Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT) (UROCOR)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01284608

First received: January 26, 2011

Last updated: December 21, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 26, 2011
Last Updated Date	December 21, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2011)	Metabolic syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ] Metabolic syndrome [ Time Frame: 6 months ] [ Designated as safety issue: No ] Metabolic syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ] Diabetes [ Time Frame: 3 months ] [ Designated as safety issue: No ] Diabetes [ Time Frame: 6 months ] [ Designated as safety issue: No ] Diabetes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01284608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2011)	Fracture Risk Assessment Tool (FRAx) assessment [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
Official Title ^ICMJE	Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
Brief Summary	This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Prostate cancer patients in androgen-ablaction treatment in urological departments
Condition ^ICMJE	Prostatic Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
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 ^ICMJE	Completed
Enrollment ^ICMJE	197
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Prostate cancer patient requiring androgen-ablation treatment: LHRH analogs, surgical castration, antiandrogen treatment Provision of informed consent prior to conducting any study-related procedure Exclusion Criteria: Patient involved in a Clinical Trial
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01284608
Other Study ID Numbers ^ICMJE	NIS-OES-DUM-2010/1
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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