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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
  Purpose

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


Condition
Prostatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Fracture Risk Assessment Tool (FRAx) assessment [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prostate cancer patients in androgen-ablaction treatment in urological departments

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284608

Locations
Spain
Research Site
El Ejido, Almeria, Spain
Research Site
Huercal Overa, Almeria, Spain
Research Site
Merida, Badajoz, Spain
Research Site
El Hospitalet de Llobregat, Barcelona, Spain
Research Site
Sabadell, Barcelona, Spain
Research Site
Aranda de Duero, Burgos, Spain
Research Site
Miranda de Ebro, Burgos, Spain
Research Site
Ferrol, Coru?a, Spain
Research Site
San Sebastian, Guipuzcoa, Spain
Research Site
Palma de Mallorca, Illes Balears, Spain
Research Site
Logrono, La Rioja, Spain
Research Site
Monforte (casco Urbano), Lugo, Spain
Research Site
Alcala de Henares, Madrid, Spain
Research Site
Coslada, Madrid, Spain
Research Site
Majadahonda, Madrid, Spain
Research Site
San Sebastian de Los Reyes, Madrid, Spain
Research Site
Antequera, Malaga, Spain
Research Site
Vigo, Pontevedra, Spain
Research Site
Osuna, Sevilla, Spain
Research Site
Reus, Tarragona, Spain
Research Site
Baracaldo, Vizcaya, Spain
Research Site
Bilbao, Vizcaya, Spain
Research Site
Galdakao, Vizcaya, Spain
Research Site
Calatayud, Zaragoza, Spain
Research Site
Albacete, Spain
Research Site
Barcelona, Spain
Research Site
Cordoba, Spain
Research Site
Granada, Spain
Research Site
Guadalajara, Spain
Research Site
Jaen, Spain
Research Site
Madrid, Spain
Research Site
Toledo, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01284608     History of Changes
Other Study ID Numbers: NIS-OES-DUM-2010/1
Study First Received: January 26, 2011
Last Updated: December 21, 2012
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Observational
prospective
metabolic changes
metabolic syndrome
 diabetes
prostatic cancer
risk fracture

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013